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TRILUMINATE Pivotal Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03904147
Recruitment Status : Active, not recruiting
First Posted : April 5, 2019
Results First Posted : March 27, 2024
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Tricuspid Regurgitation
Intervention Device: TriClipTM Device
Enrollment 572
Recruitment Details The last 12-month follow-up visit for the 350 randomized subjects (primary analysis cohort) occurred on November 18, 2022. The last 12-month follow-up visit for the 100 Single-arm subjects (primary analysis cohort) occurred on November 1, 2022. Follow-up through 5years is ongoing for all cohorts.
Pre-assignment Details  
Arm/Group Title Randomized - Device Group Randomized - Control Group Single Arm Group
Hide Arm/Group Description Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion Subjects will continue to be managed on medical therapy, per physician discretion Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
Period Title: Overall Study
Started 175 175 100
Completed 152 149 84
Not Completed 23 26 16
Reason Not Completed
Death             16             14             15
Withdrawal by Subject             7             12             1
Arm/Group Title Randomized - Device Group Randomized - Control Group Single Arm Group Total
Hide Arm/Group Description Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion Subjects will continue to be managed on medical therapy, per physician discretion Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion. Total of all reporting groups
Overall Number of Baseline Participants 175 175 100 450
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 175 participants 100 participants 450 participants
78.0  (7.4) 77.8  (7.2) 80.4  (6.2) 78.5  (7.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 100 participants 450 participants
Female
98
  56.0%
94
  53.7%
53
  53.0%
245
  54.4%
Male
77
  44.0%
81
  46.3%
47
  47.0%
205
  45.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 100 participants 450 participants
Hispanic or Latino
5
   2.9%
9
   5.1%
4
   4.0%
18
   4.0%
Not Hispanic or Latino
163
  93.1%
153
  87.4%
94
  94.0%
410
  91.1%
Unknown or Not Reported
7
   4.0%
13
   7.4%
2
   2.0%
22
   4.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 100 participants 450 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
7
   4.0%
7
   4.0%
3
   3.0%
17
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   4.0%
10
   5.7%
7
   7.0%
24
   5.3%
White
149
  85.1%
143
  81.7%
87
  87.0%
379
  84.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
   6.3%
15
   8.6%
3
   3.0%
29
   6.4%
Prior Aortic or Mitral Valve Intervention  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 100 participants 450 participants
68
  38.9%
61
  34.9%
44
  44.0%
173
  38.4%
1.Primary Outcome
Title For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement
Hide Description

Analysis of hierarchical composite of all-cause death or tricuspid valve surgery, heart failure hospitalizations, and KCCQ improvement of at least 15 points was performed in ITT population using Finkelstein-Schoenfeld method.

A win ratio was also calculated to descriptively quantify the magnitude of treatment benefits. The win ratio is calculated as the ratio of the number of wins in Device versus Control patients. The primary analysis population consisted of 175 Device patients and 175 Control patients, resulting in 30,625 Device-Control patient pairs (i.e., 175 × 175).
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Randomized - Device Group Randomized - Control Group
Hide Arm/Group Description:
Subjects received Device treatment.
Subjects received medical therapy alone.
Overall Number of Participants Analyzed 175 175
Measure Type: Number
Unit of Measure: wins in the patient pairs
11,246 7,791
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized - Device Group, Randomized - Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0311
Comments [Not Specified]
Method Finkelstein-Schoenfeld Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Win Ratio
Estimated Value 1.44
Estimation Comments The Win Ratio provides an estimation of the treatment effect.
2.Primary Outcome
Title For Single-Arm Cohort: Rate of Survival Through 12 Months With a Quality of Life Improvement (Assessed Using KCCQ Overall Score) of at Least 10 Points Compared to Baseline.
Hide Description This outcome will be assessed as the percentage of subjects meeting the definition of the endpoint.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description

Nine (9) subjects were not included in the primary endpoint analysis due to:

  • KCCQ not available at 12-month visit (n=6)

    • Subject missed 12-month visit (n=3)
    • Subject declined to complete KCCQ (n=2)
    • Subject did not complete a 12-month visit due to COVID-19 (n=1)
  • Subject experienced hospitalization or death related to COVID-19 prior to 12-month follow-up visit (n=2)
  • Subject withdrew prior to 12-month visit (n=1)
Arm/Group Title Single Arm Group
Hide Arm/Group Description:
Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: percentage of participants
46.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method exact test
Comments [Not Specified]
3.Secondary Outcome
Title For Randomized Cohort - Device Group Only: Rate of Kaplan-Meier Estimate (SE) of Freedom From Major Adverse Events (MAE) Occurring Within 30 Days Post-procedure
Hide Description Freedom from major adverse events (MAE) was assessed in the Attempted Procedure population (n=172). MAEs included cardiovascular mortality, new onset renal failure, endocarditis requiring surgery, and non-elective cardiovascular surgery for TriClip device-related AE post-index procedure.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Randomized - Device Group
Hide Arm/Group Description:
Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: percentage of participants
98.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized - Device Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Z test
Comments [Not Specified]
4.Secondary Outcome
Title For Randomized Cohort: Change in Quality of Life as Assessed by KCCQ Score
Hide Description The mean change in KCCQ score between 12 months and baseline in the Device and Control groups will be compared, while adjusting for the baseline KCCQ score. The primary analysis for this endpoint imputed a KCCQ score of 0 at 12-month visit for all subjects who experienced a heart failure related cardiovascular death or received tricuspid valve surgery prior to completing 12-month follow-up. All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.
Time Frame 12 months minus baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Forty (11%) of the 350 subjects (20 Device, 20 Control) were not included in this endpoint due to missing paired KCCQ values at baseline and 12 months.
Arm/Group Title Randomized - Device Group Randomized - Control Group
Hide Arm/Group Description:
Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion
Subjects will continue to be managed on medical therapy, per physician discretion
Overall Number of Participants Analyzed 155 155
Mean (Standard Deviation)
Unit of Measure: scores on a scale
12.0  (25.8) 1.0  (21.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized - Device Group, Randomized - Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA model
Comments [Not Specified]
5.Secondary Outcome
Title For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit
Hide Description The percentage of subjects with tricuspid regurgitation reduced to moderate or less at 30-day visit in the Device Group will be compared with that in the Control Group. Tricuspid regurgitation severity will be graded on a 5-point scale: trace/mild, moderate, severe (severe 3), massive (severe 4), and torrential (severe 5), which has frequently been used in recent interventional tricuspid studies to categorize tricuspid regurgitation severity. This grading system follows the 2017 ASE guidelines (Zoghbi WA, Adams D, Bonow RO et al. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr 2017;30:303-371.), and further stratifies the traditional "severe" category into severe (Severe 3), massive (Severe 4), and torrential (Severe 5).
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Forty-one (41, or 12%) of the 350 subjects (13 Device, 28 Control) were not included in the analysis of this endpoint due to TR not available at 30 days.
Arm/Group Title Randomized - Device Group Randomized -Control Group
Hide Arm/Group Description:
Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion
Subjects will continue to be managed on medical therapy, per physician discretion
Overall Number of Participants Analyzed 162 147
Measure Type: Number
Unit of Measure: percentage of participants
Trace 10.5 0.7
Mild 39.5 0.7
Moderate 37.0 4.1
Severe 3 11.1 22.4
Severe 4 0.6 21.8
Severe 5 1.2 50.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized - Device Group, Randomized -Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-square test
Comments [Not Specified]
6.Secondary Outcome
Title For Randomized Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months
Hide Description The primary analysis for this endpoint imputed a 6MWT distance of 0 meters for all subjects who experienced a heart failure related cardiovascular death or received tricuspid valve surgery prior to completing 12-month follow-up. Subjects who were unable to exercise due to cardiac reasons were also assigned a 6MWT distance of 0 meters at 12-month follow-up. Other subjects with missing 6MWT distance at either baseline or 12-month follow-up were excluded from the analysis.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Eighty-three (24%) of the 350 subjects (44 Device, 39 Control) were not included in this endpoint due to missing paired 6MWT values at baseline and 12 months.
Arm/Group Title Randomized - Device Group Randomized - Control Group
Hide Arm/Group Description:
Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion
Subjects will continue to be managed on medical therapy, per physician discretion
Overall Number of Participants Analyzed 131 136
Mean (Standard Deviation)
Unit of Measure: meters
-5.1  (131.4) -28.1  (122.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized - Device Group, Randomized - Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2482
Comments [Not Specified]
Method ANCOVA model
Comments [Not Specified]
7.Secondary Outcome
Title For Single-Arm Cohort: The Percentage of Subjects With TR Reduction by at Least 1 Grade at 30-Day Follow-up
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Twelve subjects were not included in the analysis of this endpoint due to missing paired TR severity at baseline and 30 days.
Arm/Group Title Single Arm Group
Hide Arm/Group Description:
Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: percentage of participants
98.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact test
Comments [Not Specified]
8.Secondary Outcome
Title For Single-Arm Cohort: Rate of Freedom From MAE Through 30 Days
Hide Description Freedom from MAE occurring after procedure attempt (femoral vein puncture) at 30 days. Components of MAE consist of Cardiovascular Mortality, New Onset Renal Failure, Endocarditis Requiring Surgery, and Non-Elective Cardiovascular Surgery for TriClip device-related AE post-index procedure.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
One subject (Subject 1300) withdrew from the study prior to 30 days without experiencing any MAE and was therefore excluded from the analysis.
Arm/Group Title Single Arm Group
Hide Arm/Group Description:
Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: percentage of participants
100.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial exact method
Comments [Not Specified]
9.Secondary Outcome
Title For Single-Arm Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months
Hide Description This analysis imputed a 6MWT distance of 0 meters for all subjects who were unable to exercise due to cardiac reasons. However, there were no subjects unable to exercise due to cardiac reasons and therefore no imputation was performed. Subjects with missing 6MWT distance at either baseline or 12-month follow-up were excluded from the analysis.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Twenty-nine (29%) subjects were not included in the primary analysis due to missing 6MWT values at baseline and/or 12 months.
Arm/Group Title Single Arm Group
Hide Arm/Group Description:
Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: meter
13.7  (92.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1090
Comments [Not Specified]
Method normal approximation
Comments [Not Specified]
10.Secondary Outcome
Title Recurrent HF Hospitalizations at 24 Months
Hide Description H0: HR(24M)>1; H1: HR(24M)≤1
Time Frame 24 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Freedom From All-cause Mortality, Tricuspid Valve Surgery, and Tricuspid Valve Intervention at 24 Months
Hide Description H0: Survival curves of the two groups through 24 months are the same. H1: Survival curves of the two groups through 24 months are different.
Time Frame 24 months
Outcome Measure Data Not Reported
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Randomized - Device Group Randomized - Control Group Randomized - Single Arm Group
Hide Arm/Group Description Subjects will undergo TriClipTM implantation and will continue to be managed on medical therapy, per physician discretion Subjects will continue to be managed on medical therapy, per physician discretion Subjects will receive the TriClip TM device and will continue to be managed on medical therapy, per physician discretion.
All-Cause Mortality
Randomized - Device Group Randomized - Control Group Randomized - Single Arm Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/175 (8.57%)   13/175 (7.43%)   15/100 (15.00%) 
Hide Serious Adverse Events
Randomized - Device Group Randomized - Control Group Randomized - Single Arm Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   85/175 (48.57%)   73/175 (41.71%)   62/100 (62.00%) 
Blood and lymphatic system disorders       
ANAEMIA †  5/175 (2.86%)  3/175 (1.71%)  6/100 (6.00%) 
ANAEMIA MACROCYTIC †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
LEUKOCYTOSIS †  2/175 (1.14%)  0/175 (0.00%)  0/100 (0.00%) 
THROMBOCYTOPENIA †  3/175 (1.71%)  1/175 (0.57%)  1/100 (1.00%) 
Cardiac disorders       
AORTIC VALVE STENOSIS †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
ARRHYTHMIA †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
ATRIAL FIBRILLATION †  10/175 (5.71%)  7/175 (4.00%)  4/100 (4.00%) 
ATRIAL FLUTTER †  1/175 (0.57%)  2/175 (1.14%)  0/100 (0.00%) 
ATRIOVENTRICULAR BLOCK COMPLETE †  1/175 (0.57%)  0/175 (0.00%)  1/100 (1.00%) 
BRADYCARDIA †  3/175 (1.71%)  1/175 (0.57%)  2/100 (2.00%) 
CARDIAC ARREST †  0/175 (0.00%)  2/175 (1.14%)  1/100 (1.00%) 
CARDIAC FAILURE †  26/175 (14.86%)  20/175 (11.43%)  21/100 (21.00%) 
CARDIAC FAILURE ACUTE †  2/175 (1.14%)  1/175 (0.57%)  0/100 (0.00%) 
CARDIAC FAILURE CONGESTIVE †  1/175 (0.57%)  1/175 (0.57%)  0/100 (0.00%) 
CARDIAC TAMPONADE †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
CARDIOGENIC SHOCK †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
CARDIOMYOPATHY †  0/175 (0.00%)  0/175 (0.00%)  2/100 (2.00%) 
CHORDAE TENDINAE RUPTURE †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
CORONARY ARTERY DISEASE †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
MITRAL VALVE INCOMPETENCE †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
MYOCARDIAL INFARCTION †  1/175 (0.57%)  0/175 (0.00%)  2/100 (2.00%) 
PERICARDIAL EFFUSION †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
SICK SINUS SYNDROME †  2/175 (1.14%)  1/175 (0.57%)  1/100 (1.00%) 
SINUS ARREST †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
SINUS ARRHYTHMIA †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
TRICUSPID VALVE INCOMPETENCE †  6/175 (3.43%)  7/175 (4.00%)  11/100 (11.00%) 
VENTRICULAR TACHYCARDIA †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
Endocrine disorders       
ADRENAL MASS †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
HYPOPARATHYROIDISM †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
Gastrointestinal disorders       
ABDOMINAL PAIN †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
ASCITES †  1/175 (0.57%)  1/175 (0.57%)  1/100 (1.00%) 
DIARRHOEA †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
DYSPHAGIA †  2/175 (1.14%)  0/175 (0.00%)  1/100 (1.00%) 
GASTROINTESTINAL HAEMORRHAGE †  3/175 (1.71%)  3/175 (1.71%)  0/100 (0.00%) 
GINGIVAL BLEEDING †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
ILEUS †  2/175 (1.14%)  0/175 (0.00%)  1/100 (1.00%) 
RECTAL HAEMORRHAGE †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
TONGUE HAEMATOMA †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
General disorders       
ASTHENIA †  2/175 (1.14%)  0/175 (0.00%)  2/100 (2.00%) 
CHEST DISCOMFORT †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
CHEST PAIN †  1/175 (0.57%)  1/175 (0.57%)  0/100 (0.00%) 
DEATH †  2/175 (1.14%)  3/175 (1.71%)  2/100 (2.00%) 
DEVICE DEPLOYMENT ISSUE †  3/175 (1.71%)  1/175 (0.57%)  1/100 (1.00%) 
MULTI-ORGAN FAILURE †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
OEDEMA PERIPHERAL †  1/175 (0.57%)  1/175 (0.57%)  1/100 (1.00%) 
OTHERS †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
PYREXIA †  0/175 (0.00%)  1/175 (0.57%)  1/100 (1.00%) 
THROMBOSIS IN RIGHT ATRIAL LEAD †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
Hepatobiliary disorders       
CHOLANGITIS †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
Immune system disorders       
AMYLOIDOSIS †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
Infections and infestations       
APPENDICITIS †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
BACTERAEMIA †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
BRONCHITIS †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
CELLULITIS †  0/175 (0.00%)  4/175 (2.29%)  3/100 (3.00%) 
CLOSTRIDIAL INFECTION †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
CORONA VIRUS INFECTION †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
CYSTITIS †  0/175 (0.00%)  0/175 (0.00%)  2/100 (2.00%) 
DIVERTICULITIS †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
ERYSIPELAS †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
INFECTION †  0/175 (0.00%)  0/175 (0.00%)  2/100 (2.00%) 
INFECTIOUS PLEURAL EFFUSION †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
LOCALISED INFECTION †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
MENINGOENCEPHALITIS HERPETIC †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
PNEUMONIA †  2/175 (1.14%)  1/175 (0.57%)  2/100 (2.00%) 
PNEUMONIA PRIMARY ATYPICAL †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
PSEUDOMONAL SEPSIS †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
PULMONARY SEPSIS †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
SEPSIS †  4/175 (2.29%)  2/175 (1.14%)  1/100 (1.00%) 
SEPTIC SHOCK †  0/175 (0.00%)  1/175 (0.57%)  1/100 (1.00%) 
URINARY TRACT INFECTION †  3/175 (1.71%)  2/175 (1.14%)  2/100 (2.00%) 
UROSEPSIS †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
Injury, poisoning and procedural complications       
CLAVICLE FRACTURE †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
CONTUSION †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
FALL †  0/175 (0.00%)  5/175 (2.86%)  3/100 (3.00%) 
FEMUR FRACTURE †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
HIP FRACTURE †  0/175 (0.00%)  2/175 (1.14%)  0/100 (0.00%) 
INCISION SITE HAEMORRHAGE †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
RIB FRACTURE †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
ROAD TRAFFIC ACCIDENT †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
SPINAL COMPRESSION FRACTURE †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
SUBCUTANEOUS HAEMATOMA †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
SUBDURAL HAEMATOMA †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
VASCULAR ACCESS COMPLICATION †  2/175 (1.14%)  0/175 (0.00%)  0/100 (0.00%) 
VASCULAR PROCEDURE COMPLICATION †  1/175 (0.57%)  1/175 (0.57%)  0/100 (0.00%) 
VASCULAR PSEUDOANEURYSM †  2/175 (1.14%)  0/175 (0.00%)  0/100 (0.00%) 
Investigations       
BLOOD CREATININE INCREASED †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
CATHETERISATION CARDIAC †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
CORONAVIRUS TEST POSITIVE †  1/175 (0.57%)  0/175 (0.00%)  1/100 (1.00%) 
ECHOCARDIOGRAM ABNORMAL †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
ELECTROCARDIOGRAM ABNORMAL †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
INTERNATIONAL NORMALISED RATIO INCREASED †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
LIVER FUNCTION TEST ABNORMAL †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
TROPONIN INCREASED †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
Metabolism and nutrition disorders       
DEHYDRATION †  2/175 (1.14%)  1/175 (0.57%)  0/100 (0.00%) 
FAILURE TO THRIVE †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
FLUID OVERLOAD †  1/175 (0.57%)  1/175 (0.57%)  0/100 (0.00%) 
GOUT †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
HYPERGLYCAEMIA †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
HYPERKALAEMIA †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
HYPERVOLAEMIA †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
HYPOGLYCAEMIA †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
HYPOKALAEMIA †  2/175 (1.14%)  0/175 (0.00%)  2/100 (2.00%) 
HYPONATRAEMIA †  2/175 (1.14%)  2/175 (1.14%)  0/100 (0.00%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
BACK PAIN †  1/175 (0.57%)  1/175 (0.57%)  0/100 (0.00%) 
CERVICAL SPINAL STENOSIS †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
INGUINAL MASS †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
MUSCLE HAEMORRHAGE †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
MUSCULOSKELETAL PAIN †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
OSTEOARTHRITIS †  0/175 (0.00%)  3/175 (1.71%)  0/100 (0.00%) 
PAIN IN EXTREMITY †  0/175 (0.00%)  3/175 (1.71%)  0/100 (0.00%) 
RHABDOMYOLYSIS †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
ADENOCARCINOMA †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
BASAL CELL CARCINOMA †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
BLADDER CANCER †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
LUNG NEOPLASM †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
METASTASES TO CENTRAL NERVOUS SYSTEM †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
NEOPLASM MALIGNANT †  0/175 (0.00%)  1/175 (0.57%)  1/100 (1.00%) 
OVARIAN CANCER †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
PROSTATE CANCER †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
SKIN CANCER †  1/175 (0.57%)  1/175 (0.57%)  0/100 (0.00%) 
SQUAMOUS CELL CARCINOMA †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
Nervous system disorders       
CEREBRAL HAEMORRHAGE †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
CEREBROVASCULAR ACCIDENT †  3/175 (1.71%)  2/175 (1.14%)  1/100 (1.00%) 
DIZZINESS †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
ENCEPHALOPATHY †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
HEPATIC ENCEPHALOPATHY †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
METABOLIC ENCEPHALOPATHY †  0/175 (0.00%)  2/175 (1.14%)  0/100 (0.00%) 
NORMAL PRESSURE HYDROCEPHALUS †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
PARKINSON'S DISEASE †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
PERIPHERAL SENSORIMOTOR NEUROPATHY †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
SUBARACHNOID HAEMORRHAGE †  1/175 (0.57%)  1/175 (0.57%)  0/100 (0.00%) 
SYNCOPE †  4/175 (2.29%)  0/175 (0.00%)  0/100 (0.00%) 
TOXIC ENCEPHALOPATHY †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
TRANSIENT ISCHAEMIC ATTACK †  2/175 (1.14%)  0/175 (0.00%)  2/100 (2.00%) 
VOCAL CORD PARALYSIS †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
Psychiatric disorders       
CONFUSIONAL STATE †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
Renal and urinary disorders       
HAEMATURIA †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
NEPHROPATHY †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
RENAL FAILURE †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
RENAL FAILURE ACUTE †  7/175 (4.00%)  5/175 (2.86%)  9/100 (9.00%) 
RENAL FAILURE CHRONIC †  2/175 (1.14%)  0/175 (0.00%)  1/100 (1.00%) 
URINARY RETENTION †  1/175 (0.57%)  0/175 (0.00%)  1/100 (1.00%) 
Reproductive system and breast disorders       
BENIGN PROSTATIC HYPERPLASIA †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
Respiratory, thoracic and mediastinal disorders       
ACUTE RESPIRATORY FAILURE †  2/175 (1.14%)  0/175 (0.00%)  1/100 (1.00%) 
ASPIRATION †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
DYSPNOEA †  2/175 (1.14%)  0/175 (0.00%)  0/100 (0.00%) 
HYPOXIA †  3/175 (1.71%)  0/175 (0.00%)  1/100 (1.00%) 
LUNG INFILTRATION †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
PLEURAL EFFUSION †  1/175 (0.57%)  2/175 (1.14%)  3/100 (3.00%) 
PNEUMONIA ASPIRATION †  1/175 (0.57%)  1/175 (0.57%)  0/100 (0.00%) 
PULMONARY CONGESTION †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
PULMONARY EMBOLISM †  0/175 (0.00%)  1/175 (0.57%)  2/100 (2.00%) 
PULMONARY HYPERTENSION †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
PULMONARY OEDEMA †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
RESPIRATORY ARREST †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
RESPIRATORY DISTRESS †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
RESPIRATORY FAILURE †  1/175 (0.57%)  2/175 (1.14%)  0/100 (0.00%) 
Skin and subcutaneous tissue disorders       
DECUBITUS ULCER †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
SKIN ULCER †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
Social circumstances       
EXERCISE LACK OF †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
Surgical and medical procedures       
HIP ARTHROPLASTY †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
MEDICAL DEVICE IMPLANTATION †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
ROTATOR CUFF REPAIR †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
STENT PLACEMENT †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
TRANSURETHRAL PROSTATECTOMY †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
TRICUSPID VALVE REPAIR †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
Vascular disorders       
AORTIC STENOSIS †  0/175 (0.00%)  1/175 (0.57%)  0/100 (0.00%) 
HAEMORRHAGE †  14/175 (8.00%)  7/175 (4.00%)  8/100 (8.00%) 
HYPERTENSION †  2/175 (1.14%)  0/175 (0.00%)  0/100 (0.00%) 
HYPOTENSION †  5/175 (2.86%)  0/175 (0.00%)  4/100 (4.00%) 
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE †  1/175 (0.57%)  1/175 (0.57%)  0/100 (0.00%) 
PERIPHERAL ISCHAEMIA †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
SHOCK †  0/175 (0.00%)  0/175 (0.00%)  1/100 (1.00%) 
VENA CAVA THROMBOSIS †  1/175 (0.57%)  0/175 (0.00%)  0/100 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Randomized - Device Group Randomized - Control Group Randomized - Single Arm Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/175 (16.57%)   28/175 (16.00%)   33/100 (33.00%) 
Cardiac disorders       
ATRIAL FIBRILLATION †  5/175 (2.86%)  1/175 (0.57%)  5/100 (5.00%) 
CARDIAC FAILURE †  6/175 (3.43%)  9/175 (5.14%)  9/100 (9.00%) 
Renal and urinary disorders       
RENAL FAILURE ACUTE †  6/175 (3.43%)  3/175 (1.71%)  10/100 (10.00%) 
Respiratory, thoracic and mediastinal disorders       
DYSPNOEA †  3/175 (1.71%)  10/175 (5.71%)  4/100 (4.00%) 
Vascular disorders       
HAEMORRHAGE †  9/175 (5.14%)  5/175 (2.86%)  5/100 (5.00%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Natalie Richardson, Senior Clinical Project Manager
Organization: Abbott
Phone: 651-756-3842
EMail: natalie.richardson@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03904147    
Other Study ID Numbers: ABT-CIP-10249
First Submitted: April 3, 2019
First Posted: April 5, 2019
Results First Submitted: January 9, 2024
Results First Posted: March 27, 2024
Last Update Posted: April 8, 2024