Reveal LINQ™ Heart Failure (LINQ HF)

• ClinicalTrials.gov Identifier: NCT02758301
• Recruitment Status: Completed
• First Posted: May 2, 2016
• Results First Posted: November 12, 2019
• Last Update Posted: November 12, 2019
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Information provided by (Responsible Party): Medtronic Cardiac Rhythm and Heart Failure

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Condition: Heart Failure
• Intervention: Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)
• Enrollment: 112

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Reveal LINQ Cohort	Enrolled But Not Inserted Group
Arm/Group Description	Subjects inserted with a Reveal LINQ implantable cardiac monitor	Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
Period Title: Overall Study
Started	104	8
Completed	70	0
Not Completed	34	8
Reason Not Completed
Death	12	0
Physician Decision	10	1
Withdrawal by Subject	5	6
Lost to Follow-up	7	0
Protocol Violation	0	1

Baseline Characteristics

Arm/Group Title		Reveal LINQ Cohort	Enrolled But Not Inserted Group	Total
Arm/Group Description		Subjects inserted with a Reveal LINQ implantable cardiac monitor	Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device, but had a Baseline Form Completed.	Total of all reporting groups
Overall Number of Baseline Participants		104	7	111
Baseline Analysis Population Description		Enrolled subjects who underwent an insertion of a Reveal LINQ device
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	104 participants	7 participants	111 participants
		66.8 (10.9)	69.4 (14.7)	66.9 (11.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	104 participants	7 participants	111 participants
	Female	67 64.4%	2 28.6%	69 62.2%
	Male	37 35.6%	5 71.4%	42 37.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	104 participants	7 participants	111 participants
	Hispanic or Latino	3 2.9%	0 0.0%	3 2.7%
	Not Hispanic or Latino	101 97.1%	7 100.0%	108 97.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	104 participants	7 participants	111 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	17 16.3%	1 14.3%	18 16.2%
	White	86 82.7%	6 85.7%	92 82.9%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 1.0%	0 0.0%	1 0.9%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	104 participants	7 participants	111 participants
		104 100.0%	7 100.0%	111 100.0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event
Description	A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events.; Admission with primary diagnosis of HF; Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: Admission with secondary/tertiary diagnosis of HF Emergency Department Ambulance Observation Unit Urgent Care HF/Cardiology Clinic Up to 2 ADHF events were intended to be allowed per subject: One had to be at least 30 days post-Reveal LINQ insertion and is summarized in this section, and; A possible second ADHF event must be greater than 90 days after the first ADHF event Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
Time Frame	30 days post-Reveal LINQ insertion to 3 years post-implant

Outcome Measure Data

Analysis Population Description

Subjects inserted with a Reveal LINQ device

Arm/Group Title	Reveal LINQ Cohort	Enrolled But Not Inserted Group
Arm/Group Description:	Subjects inserted with a Reveal LINQ implantable cardiac monitor	Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
Overall Number of Participants Analyzed	104	0
Measure Type: Number; Unit of Measure: participants
	36

2. Primary Outcome

Title	Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events
Description	A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events.; Admission with primary diagnosis of HF; Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: Admission with secondary/tertiary diagnosis of HF Emergency Department Ambulance Observation Unit Urgent Care HF/Cardiology Clinic Up to two ADHF events per subject were intended to be evaluated. The first must be at least 30 days post-Reveal LINQ insertion, and the second, summarized in this section, must be greater than 90 days following the first ADHF event. Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
Time Frame	> 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant

Outcome Measure Data

Analysis Population Description

Subjects who experienced an ADHF event at least 30 days post-Reveal LINQ insertion

Arm/Group Title	Reveal LINQ Cohort	Enrolled But Not Inserted Group
Arm/Group Description:	Subjects inserted with a Reveal LINQ implantable cardiac monitor	Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
Overall Number of Participants Analyzed	36	0
Measure Type: Number; Unit of Measure: participants
	12

Adverse Events

Time Frame	Adverse events were collected from the period of study consent through device (Reveal LINQ) insertion and throughout follow-up. The last scheduled follow-up visit was 12 months post-device insertion, and then subjects were followed until study closure.
Adverse Event Reporting Description	Only adverse events that the study investigators determined were related to the Reveal LINQ system or insertion procedure were collected in this study. Adverse events which were not related to either the Reveal LINQ system or Reveal LINQ insertion procedure were not reported.
Arm/Group Title	Reveal LINQ Cohort	Enrolled But Not Inserted Group
Arm/Group Description	Subjects inserted with a Reveal LINQ implantable cardiac monitor	Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
All-Cause Mortality
	Reveal LINQ Cohort	Enrolled But Not Inserted Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	12/104 (11.54%)	0/8 (0.00%)
Serious Adverse Events
	Reveal LINQ Cohort	Enrolled But Not Inserted Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/104 (0.00%)	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Reveal LINQ Cohort	Enrolled But Not Inserted Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/104 (0.00%)	0/0

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Lindsay Werder, Senior Clinical Research Specialist
• Organization: Medtronic, PLC
• Phone: 6123003066
• EMail: lindsay.k.werder@medtronic.com

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT02758301
• Other Study ID Numbers: LINQ HF
• First Submitted: April 27, 2016
• First Posted: May 2, 2016
• Results First Submitted: June 12, 2019
• Results First Posted: November 12, 2019
• Last Update Posted: November 12, 2019