Reveal LINQ™ Heart Failure | Clinical Trial

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Green Hospital, La Jolla, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):

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

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)

Treatment and study plan

Reveal LINQ™ Insertable Cardiac Monitor (ICM)

Device

Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download

Primary outcomes

Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event

Time frame: 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.
Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events

Time frame: > 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: LINQ HF

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: May 2, 2016
Registry last updated: Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed