Reveal LINQ™ Heart Failure

Heart Failure Clinical Trial

— LINQ HF  

Official title:

Reveal LINQ™ Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758301
• Other study ID #: LINQ HF
• Status: Completed
• Start date: June 8, 2016
• Est. completion date: December 4, 2018

Study information

• Verified date: October 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

3. 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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Reveal LINQ™ Insertable Cardiac Monitor (ICM)
Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download

Locations

Country	Name	City	State
United States	Austin Heart PA	Austin	Texas
United States	Bay Area Cardiology Associates PA	Brandon	Florida
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	The Lindner Research Center	Cincinnati	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Mid America Heart Institute	Kansas City	Missouri
United States	Scripps Green Hospital	La Jolla	California
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Centra Medical Group Stroobants Cardiovascular Center	Lynchburg	Virginia
United States	Louisiana State University	New Orleans	Louisiana
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Oregon Health & Science University Hospital	Portland	Oregon
United States	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Prairie Education & Research Cooperative	Springfield	Illinois
United States	Cardiology Associates of North Mississippi	Tupelo	Mississippi
United States	Lourdes Cardiology Services	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event	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.	30 days post-Reveal LINQ insertion to 3 years post-implant
Primary	Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events	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.	> 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant