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Personalized Therapy Study - HFRS (TriageHF) Post Approval Study | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study

NCT04489225•Medtronic

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.

Detailed Description

The HFRS PAS is a global, prospective, observational, multi-site study. Patients implanted with a Medtronic Cobalt™ XT CRT (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)) or ICD device who are enrolled in the Medtronic CareLink (CL) Network and the PSR will be followed per the standard of care practices of their care provider.

Eligibility

Age

All ages

Sex

ALL

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 is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results.

Locations (92)

Southwest EP

Chandler, Arizona, United States

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

Key Dates

Start Date

August 1, 2020

Primary Completion Date

December 6, 2024

Completion Date

January 31, 2028

Last Updated

October 20, 2025

Enrollment

2,200

ESTIMATED participants

Conditions

Heart Failure

Interventions

Observational

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

Inclusion Criteria

Exclusion Criteria

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