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Clinical Trials in the UK / NCT04489225
Active, not recruiting Observational

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
No
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)

FacilityCityRegionStatus
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

Product Surveillance Registry Recruiting
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) 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

Other trials for the same condition

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices Active, not recruiting
A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF) Recruiting
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation Recruiting
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation Active, not recruiting
A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy 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