Clinical trial NCT02758301: Reveal LINQ™ Heart Failure
Official title: Reveal LINQ™ Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event
timeFrame: 30 days post-Reveal LINQ insertion to 3 years post-implant
measure: Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events
timeFrame: > 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Brandon
country: United States
facility: Bay Area Cardiology Associates PA
state: Florida
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Saint Cloud
country: United States
facility: CentraCare Heart & Vascular Center
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Kansas City
country: United States
facility: Mid America Heart Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University Hospital
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Austin Heart PA
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Lynchburg
country: United States
facility: Centra Medical Group Stroobants Cardiovascular Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
References: