Trial Outcomes & Findings for Reveal LINQ™ Heart Failure (NCT NCT02758301)

NCT ID: NCT02758301

Last Updated: 2019-11-12

Results Overview

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: 1. Admission with secondary/tertiary diagnosis of HF 2. Emergency Department 3. Ambulance 4. Observation Unit 5. Urgent Care 6. HF/Cardiology Clinic Up to 2 ADHF events were intended to be allowed per subject: 1. One had to be at least 30 days post-Reveal LINQ insertion and is summarized in this section, and 2. 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.

• Recruitment status: COMPLETED
• Target enrollment: 112 participants
• Primary outcome timeframe: 30 days post-Reveal LINQ insertion to 3 years post-implant
• Results posted on: 2019-11-12

Participant Flow

Participant milestones

Measure	Reveal LINQ Cohort Subjects inserted with a Reveal LINQ implantable cardiac monitor	Enrolled But Not Inserted Group Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
Overall Study STARTED	104	8
Overall Study COMPLETED	70	0
Overall Study NOT COMPLETED	34	8

Reasons for withdrawal

Measure	Reveal LINQ Cohort Subjects inserted with a Reveal LINQ implantable cardiac monitor	Enrolled But Not Inserted Group Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
Overall Study Death	12	0
Overall Study Physician Decision	10	1
Overall Study Withdrawal by Subject	5	6
Overall Study Lost to Follow-up	7	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Reveal LINQ™ Heart Failure

Baseline characteristics by cohort

Measure	Reveal LINQ Cohort n=104 Participants Subjects inserted with a Reveal LINQ implantable cardiac monitor	Enrolled But Not Inserted Group n=7 Participants 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 n=111 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 10.9 • n=5 Participants	69.4 years STANDARD_DEVIATION 14.7 • n=7 Participants	66.9 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	2 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	5 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	101 Participants n=5 Participants	7 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	1 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	86 Participants n=5 Participants	6 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	104 Participants n=5 Participants	7 Participants n=7 Participants	111 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-Reveal LINQ insertion to 3 years post-implant

Population: Subjects inserted with a Reveal LINQ device

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:

1. Admission with secondary/tertiary diagnosis of HF

2. Emergency Department

3. Ambulance

4. Observation Unit

5. Urgent Care

6. HF/Cardiology Clinic

Up to 2 ADHF events were intended to be allowed per subject:

1. One had to be at least 30 days post-Reveal LINQ insertion and is summarized in this section, and

2. 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.

Outcome measures

Measure	Reveal LINQ Cohort n=104 Participants Subjects inserted with a Reveal LINQ implantable cardiac monitor	Enrolled But Not Inserted Group Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event	36 participants	—

PRIMARY outcome

Timeframe: > 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant

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

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:

1. Admission with secondary/tertiary diagnosis of HF

2. Emergency Department

3. Ambulance

4. Observation Unit

5. Urgent Care

6. 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.

Outcome measures

Measure	Reveal LINQ Cohort n=36 Participants Subjects inserted with a Reveal LINQ implantable cardiac monitor	Enrolled But Not Inserted Group Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events	12 participants	—

Adverse Events

Reveal LINQ Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 12 deaths

Enrolled But Not Inserted Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lindsay Werder, Senior Clinical Research Specialist

Medtronic, PLC

Phone: 6123003066

Email: lindsay.k.werder@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60