The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CLACBAC
Previous Study | Return to List | Next Study

Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population (CLACBAC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185142
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

Tracking Information
First Submitted Date November 25, 2019
First Posted Date December 4, 2019
Last Update Posted Date October 3, 2022
Actual Study Start Date October 16, 2015
Estimated Primary Completion Date November 16, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 30, 2019)
  • Recurrence of atrial arrhythmia [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    The proportion of patients have recurrent atrial arrhythmia, including atrial tachycardia lasting longer than 30 seconds, atrial flutter, and atrial fibrillation. Detected by either ECG or 24 Holter monitor.
  • Incidence of stroke [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    the proportion of patients have either hemorrhagic or ischemic stroke confirmed by CT or MRI.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 30, 2019)
  • All-cause death [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Death event due to any cause
  • Cardiovascular death [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    death due to cardiovascular cause
  • Major hemorrhagic events [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Intracranial hemorrhage, gastrointestinal bleeding, or any overt bleeding with hemoglobin drop ≥3 to 5 g/dL.
  • Myocardial infarction [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Diagnosed myocardial infarction with or without ST segment elevation.
  • Peripheral vascular embolism [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Arterial or venous thrombosis except cardiac or cerebral vascular embolism confirmed by imaging examination.
  • Rehospitalization due to cardiovascular events [ Time Frame: Since the start of the procedure to 5 years. ]
    Inpatient admission or emergency department admission with cardiovascular causes.
  • Redo-ablation [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Ablation intended to treat recurrent atrial arrhythmia
  • Withdrawal of oral anticoagulants [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    The proportion of patients stop oral anticoagulation therapy including warfarin, dabigatran, or rivaroxaban.
  • Residual flow [ Time Frame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. ]
    Residual flow between LAAC device and LAA measured by TEE
  • LAAC device position [ Time Frame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. ]
    displacement of LAAC device evaluated by TEE
  • Device related thrombus [ Time Frame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. ]
    Thrombus surrounding or attached to the LAAC device detected by TEE
  • Atrioesophageal fistula [ Time Frame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. ]
    Fistula between left atrium and esophagus detected by TEE.
  • Pericardial effusion [ Time Frame: Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Any amount of pericardial effusion detected by TTE or TEE
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population
Official Title Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Atrial Fibrillation Population
Brief Summary Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in Chinese population.
Detailed Description

the investigators aimed to observe the clinical outcome of combining cryoballoon ablation (CBA) with left atrial appendage closure (LAAC) in drug-refractory non-valvular atrial fibrillation patients, who have high risk of stroke or hemorrhage, or contraindication of long-term oral anticoagulants (OACs).

The combined procedure was completed using CBA following LAAC. Generally, 3-month OACs, following 3-month double antiplatelet therapy, and lifelong single platelet therapy was recommended as antithrombotic regimen.

At 3rd,6th,12th and every year after since the procedure, Holter and transoesophageal echocardiography monitoring, and outpatient follow-up was applied to every patient.

The safety was evaluated by all-cause mortality, peri- and postprocedural complications. While the efficacy was evaluated through the freedom of atrial arrhythmia, stroke incidence, and withdrawal of OACs.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Chinese with documented non-valvular atrial fibrillation who meet the inclusion criteria while without any of the exclusion criteria.
Condition Atrial Fibrillation
Intervention Combination Product: cryoballoon ablation combining with left atrial appendage closure
cryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes.
Study Groups/Cohorts combined procedure group
patients underwent cryoballoon ablation and left atrial appendage closure
Intervention: Combination Product: cryoballoon ablation combining with left atrial appendage closure
Publications * Ren Z, Zheng Y, Zhang J, Yang H, Wu J, Li H, Guo R, Meng W, Zhang J, Sun H, Xu Y, Zhao D. Patients With Larger Left Atrial Appendage Orifice Presented Worse Prognosis Contributed by Acute Heart Failure After Left Atrial Appendage Closure. J Am Heart Assoc. 2022 Sep 20;11(18):e026309. doi: 10.1161/JAHA.122.026309. Epub 2022 Sep 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 30, 2019)		 150
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 16, 2024
Estimated Primary Completion Date November 16, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Drug refractory non-valvular paroxysmal atrial fibrillation patients,

Inclusion Criteria:

  1. CHA2DS2-VASc score≥2 or HAS-BLED score≥3,
  2. having contraindications to long-term oral anticoagulants (OACs),
  3. refuse OAC therapy despite explanation.

Exclusion Criteria:

  1. thrombus in left atrium (LA) or left atrial appendage (LAA) presented and confirmed by transoesophageal echocardiograph (TEE),
  2. oversized LA (LA diameter>65mm by TTE) or LAA (LAA opening>35mm) through TEE,
  3. pericardial effusion (≥4mm by TTE or TEE),
  4. hemodynamic unstable patients,
  5. patients with active hemorrhagic diseases,
  6. ischemic or hemorrhagic stroke within 30 days.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Zhongyuan Ren, MD +86 18862186450 cloudyrzy@gmail.com
Contact: Dongdong Zhao, MD, PhD 249620601@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04185142
Other Study ID Numbers CLACBAC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Ya-Wei Xu, Shanghai 10th People's Hospital
Original Responsible Party Same as current
Current Study Sponsor Shanghai 10th People's Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Yawei Xu, MD, PhD Department of Cardiology, Shanghai Tenth People's Hospital
PRS Account Shanghai 10th People's Hospital
Verification Date September 2022