Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

Running, not enrolling

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT04489225

Run by

Medtronic

People needed

2200

Starts

2020-08-01

Expected to finish

2028-01-31

Last updated by the study team

2025-10-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Saint Vincent Heart Clinic Arkansas — Little Rock, Arkansas, United States
• Chula Vista Cardiac Center — Chula Vista, California, United States
• Cardiovascular Consultants Medical Group — Van Nuys, California, United States
• Cardiology Associates Medical Group — Ventura, California, United States
• Colorado Springs Cardiology — Colorado Springs, Colorado, United States
• Denver Heart — Denver, Colorado, United States
• Colorado Heart and Vascular, PC — Lakewood, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale New Haven Hospital — New Have, Connecticut, United States
• Heart Rhythm Solutions — Hollywood, Florida, United States
• Baptist Health — Jacksonville, Florida, United States
• Cardiovascular Institute of Northwest Florida — Panama City, Florida, United States
• Heart & Vascular Institute of Florida — Safety Harbor, Florida, United States
• Heart Rhythm Consultants P.A. (Sarasota Memorial Research) — Sarasota, Florida, United States
• Deaconess Specialty Physicians — Evansville, Indiana, United States
• Iowa Heart — Des Moines, Iowa, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Heart and Vascular Institute — Louisville, Kentucky, United States
• TidalHealth Peninsula Regional, Inc. — Salisbury, Maryland, United States
• Associates in Cardiology PA — Silver Spring, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Southwest EP — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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