Reveal LINQ™ Heart Failure

NCT ID: NCT02758301

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-08
• Study Completion Date: 2018-12-04

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.

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Reveal LINQ™ Insertable Cardiac Monitor (ICM)

Intervention Type: DEVICE

Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download

Interventions

Reveal LINQ™ Insertable Cardiac Monitor (ICM)

Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Scripps Green Hospital

La Jolla, California, United States

Bay Area Cardiology Associates PA

Brandon, Florida, United States

Prairie Education & Research Cooperative

Springfield, Illinois, United States

Louisiana State University

New Orleans, Louisiana, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, United States

Cardiology Associates of North Mississippi

Tupelo, Mississippi, United States

Mid America Heart Institute

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Lourdes Cardiology Services

Voorhees Township, New Jersey, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

The Lindner Research Center

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Oregon Health & Science University Hospital

Portland, Oregon, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Austin Heart PA

Austin, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Centra Medical Group Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LINQ HF

Identifier Type: -

Identifier Source: org_study_id