Reveal LINQ™ Heart Failure

NCT02758301 | Completed Results FDA Device

• 1 other identifier: LINQ HF
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 19

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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: 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.

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

• 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: 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.

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

Study Arms (1)

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)

Interventions

Reveal LINQ™ Insertable Cardiac Monitor (ICM) DEVICE

Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download

Diagnostic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject population for the LINQ™ HF study is patients with heart failure with a NYHA Class III who meet all of the inclusion and none of the exclusion criteria.

You may qualify if:

• 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):
• Admission with primary diagnosis of HF within the last 6 months, OR
• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (19)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Bay Area Cardiology Associates PA

Brandon, Florida, 33511, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62701, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

Cardiology Associates of North Mississippi

Tupelo, Mississippi, 38801, United States

Location

Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University Hospital

Portland, Oregon, 97239, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Austin Heart PA

Austin, Texas, 78756, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Centra Medical Group Stroobants Cardiovascular Center

Lynchburg, Virginia, 24501, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Lindsay Werder, Senior Clinical Research Specialist
• Organization: Medtronic, PLC

lindsay.k.werder@medtronic.com

6123003066

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 2, 2016
• Study Start: June 8, 2016
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)