Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

NCT04489225 · tracked via the Priya Life Science UK tracker

Sponsor

Medtronic

Phase

Observational

Started

2020-08-01

Last updated

2025-10-20

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Observational

Observational: Observational only without any intervention

Study summary

Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * Patient has or is intended to receive or be treated with an eligible ICD or CRT device or Patients may be enrolled pre-implant and up to 30 days post-implant following confirmation of patient eligibility. * Patient is enrolled in the Medtronic CareLink® Network for remote monitoring. Exclusion Criteria: * Patient who is, or is expected to be inaccessible for follow-up * Patient with exclusion criteria required by local law * Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results.

Primary outcome measure(s)

positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure — Up to 5 years
To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure

Trial sites (92)

Facility	City	Region
Southwest EP	Chandler	Arizona
Saint Vincent Heart Clinic Arkansas	Little Rock	Arkansas
Chula Vista Cardiac Center	Chula Vista	California
Cardiovascular Consultants Medical Group	Van Nuys	California
Cardiology Associates Medical Group	Ventura	California
Colorado Springs Cardiology	Colorado Springs	Colorado
Denver Heart	Denver	Colorado
Colorado Heart and Vascular, PC	Lakewood	Colorado
Hartford Hospital	Hartford	Connecticut
Yale New Haven Hospital	New Have	Connecticut
Heart Rhythm Solutions	Hollywood	Florida
Baptist Health	Jacksonville	Florida
Cardiovascular Institute of Northwest Florida	Panama City	Florida
Heart & Vascular Institute of Florida	Safety Harbor	Florida
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)	Sarasota	Florida
Deaconess Specialty Physicians	Evansville	Indiana
Iowa Heart	Des Moines	Iowa
The University of Kansas Medical Center	Kansas City	Kansas
Norton Heart and Vascular Institute	Louisville	Kentucky
TidalHealth Peninsula Regional, Inc.	Salisbury	Maryland
Associates in Cardiology PA	Silver Spring	Maryland
Brigham and Women's Hospital	Boston	Massachusetts
Sparrow Clinical Research Institute	Lansing	Michigan
Michigan Heart	Ypsilanti	Michigan
Mayo Clinic	Rochester	Minnesota
Missouri Cardiovascular Specialists	Columbia	Missouri
University Hospital of Missouri	Columbia	Missouri
Saint Lukes Health System	Kansas City	Missouri
Washington University School of Medicine	St Louis	Missouri
Nebraska Medicine	Omaha	Nebraska
Monmouth Cardiology Associates	Eatontown	New Jersey
Presbyterian Heart Group	Albuquerque	New Mexico
South Shore University Hospital	Bay Shore	New York
Huntington Hospital	Huntington	New York
North Shore University Hospital	Manhasset	New York
Northern Westchester Hospital	Mount Kisco	New York
Long Island Jewish Medical Center	New Hyde Park	New York
New York-Presbyterian Hospital/Weill-Cornell Medical Center	New York	New York
NewYork-Presbyterian/Columbia University Irving Medical Center	New York	New York
Lenox Hill Hospital	New York	New York

+ 52 more sites — see the full list on the official registry below.

More Medtronic trials in the UK

Micra Transcatheter Pacing System Post-Approval Registry Active, not recruiting

Lead Evaluation for Defibrillation and Reliability Post Approval Study Enrolling by invitation

Enlighten Study: The EV-ICD Post Approval Registry Active, not recruiting

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting

Product Surveillance Registry Recruiting

Other trials for the same condition

Remote Monitoring and Optimization of Heart Failure Therapy Starting soon

Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk Recruiting

Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) Active, not recruiting

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients Active, not recruiting

A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04489225 on ClinicalTrials.gov ↗ ← All trials in the UK