LINQ HF: Reveal LINQ™ Heart Failure

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02758301
• Collaborator: (none)
• Enrollment: 112
• Locations: 19
• Actual Duration (Months): 29.9
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)

Detailed Description

The study is a prospective, non-randomized, multi-center, observational, pre-market clinical study. The study is expected to be conducted at up to 30 centers in the United States. Up to 300 subjects will be enrolled to achieve approximately 40 heart failure events (no more than two per subject will contribute to the cumulative total). Study subjects will be followed for up to 3 years post-insertion or until official study closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, whichever occurs first. The expected study duration is approximately 4 years representing 1.5 years of enrollments and 2.5 years of follow-up.

The LINQ™ HF study is a Non-Significant Risk Investigational Device Exemption (IDE) study. The study is utilizing the Reveal LINQ™ device with an investigational LINQ™ HF RAMware download.

Study Design

• Study Type: Observational
• Actual Enrollment: 112 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Reveal LINQ™ Heart Failure
• Actual Study Start Date: Jun 8, 2016
• Actual Primary Completion Date: Dec 4, 2018
• Actual Study Completion Date: Dec 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Diagnostic The Reveal LINQ™ Insertable Cardiac Monitor (ICM) device will be inserted in all subjects for continuous monitoring. After the Reveal LINQ™ device is inserted, the LINQ™ HF investigational RAMware will be downloaded to the LINQ™ ICM.	Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM); Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event [30 days post-Reveal LINQ insertion to 3 years post-implant]

   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.

2. Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events [> 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient is 18 years of age or older

• Patient (or patient's legally authorized representative) is willing and able to provide written informed consent

• Patient is willing and able to comply with the protocol, including follow-up visits and CareLink transmissions

• Patient is NYHA Class III, per most recent assessment or at any time within 30 days prior to enrollment

• Patient had a HF event (HF event defined as meeting any one of the following three criteria):

1. Admission with primary diagnosis of HF within the last 6 months, OR

2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings within the last 6 months:

• Admission with secondary/tertiary diagnosis of HF

• Emergency Department

• Ambulance

• Observation Unit

• Urgent Care

• HF/Cardiology Clinic

• Patient's Home, OR

1. Patient had the following BNP/NTpro-BNP within the last 3 months: If EF ≥ 50%, then BNP> 200 pg/ml or NTpro-BNP > 400 pg/ml OR If EF <50%, then BNP> 400 pg/ml or NTpro-BNP > 800 pg/ml

Exclusion Criteria:

• Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)

• Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager

• Patient has severe valvular heart disease as defined by hemodynamically significant valve stenosis and/or prosthetic heart valve

• Patient has existing IPG, ICD, CRT-D or CRT-P device

• Patient has severe renal impairment (eGFR <25mL/min)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Green Hospital	La Jolla	California	United States	92037
2	Bay Area Cardiology Associates PA	Brandon	Florida	United States	33511
3	Prairie Education & Research Cooperative	Springfield	Illinois	United States	62701
4	Louisiana State University	New Orleans	Louisiana	United States	70112
5	Sparrow Clinical Research Institute	Lansing	Michigan	United States	48912
6	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota	United States	56303
7	Cardiology Associates of North Mississippi	Tupelo	Mississippi	United States	38801
8	Mid America Heart Institute	Kansas City	Missouri	United States	64111
9	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
10	Lourdes Cardiology Services	Voorhees	New Jersey	United States	08043
11	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
12	The Lindner Research Center	Cincinnati	Ohio	United States	45219
13	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
14	Oregon Health & Science University Hospital	Portland	Oregon	United States	97239
15	Lancaster General Hospital	Lancaster	Pennsylvania	United States	17602
16	Austin Heart PA	Austin	Texas	United States	78756
17	University of Virginia	Charlottesville	Virginia	United States	22908
18	Centra Medical Group Stroobants Cardiovascular Center	Lynchburg	Virginia	United States	24501
19	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 26, 2016

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT02758301
• Other Study ID Numbers: LINQ HF
• First Posted: May 2, 2016
• Last Update Posted: Nov 12, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

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

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 Participants	104	7	111
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.8 (10.9)	69.4 (14.7)	66.9 (11.1)
Sex: Female, Male (Count of Participants)
Female	67 64.4%	2 28.6%	69 62.2%
Male	37 35.6%	5 71.4%	42 37.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2.9%	0 0%	3 2.7%
Not Hispanic or Latino	101 97.1%	7 100%	108 97.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	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%
Unknown or Not Reported	1 1%	0 0%	1 0.9%
Region of Enrollment (Count of Participants)
United States	104 100%	7 100%	111 100%

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.
Measure Participants	104	0
Number [participants]	36 34.6%

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.
Measure Participants	36	0
Number [participants]	12 11.5%

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 (%)	# Events	Affected / at Risk (%)	# Events
Total	12/104 (11.5%)		0/8 (0%)
Serious Adverse Events
	Reveal LINQ Cohort		Enrolled But Not Inserted Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Reveal LINQ Cohort		Enrolled But Not Inserted Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.