Reveal LINQ™ Heart Failure (LINQ HF)

• ClinicalTrials.gov Identifier: NCT02758301
• Recruitment Status: Completed
• First Posted: May 2, 2016
• Results First Posted: November 12, 2019
• Last Update Posted: November 12, 2019
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Information provided by (Responsible Party): Medtronic Cardiac Rhythm and Heart Failure

Tracking Information

• First Submitted Date: April 27, 2016
• First Posted Date: May 2, 2016
• Results First Submitted Date: June 12, 2019
• Results First Posted Date: November 12, 2019
• Last Update Posted Date: November 12, 2019
• Actual Study Start Date: June 8, 2016
• Actual Primary Completion Date: December 4, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 22, 2019)

• 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:
    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.
• 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:
    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.

Original Primary Outcome Measures (submitted: April 28, 2016)

• Rate of Acute Decompensated Heart Failure events [ Time Frame: 30 days post-implant 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:
    1. Admission with secondary/tertiary diagnosis of HF
    2. Emergency Department
    3. Ambulance
    4. Observation Unit
    5. Urgent Care
    6. HF/Cardiology Clinic
• Rate of Second Acute Decompensated Heart Failure 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:
    1. Admission with secondary/tertiary diagnosis of HF
    2. Emergency Department
    3. Ambulance
    4. Observation Unit
    5. Urgent Care
    6. HF/Cardiology Clinic

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reveal LINQ™ Heart Failure
• Official Title: Reveal LINQ™ Heart Failure
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Heart Failure

Intervention

Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)

Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download

Study Groups/Cohorts

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.

Intervention: Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 18, 2018): 112
• Original Estimated Enrollment (submitted: April 28, 2016): 300
• Actual Study Completion Date: December 4, 2018
• Actual Primary Completion Date: December 4, 2018 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02758301
• Other Study ID Numbers: LINQ HF
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• Original Responsible Party: Same as current
• Current Study Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medtronic Cardiac Rhythm and Heart Failure
• Verification Date: October 2019