Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

Active, not recruiting

• Conditions: Heart Failure

• Registration Number: NCT04489225
• Lead Sponsor: Medtronic

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-28
• Study Start: 2020-08-01
• Status Verified: 2024-06
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-05-12
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of HF hospitalization or HF related deaths	Up to 5 years	Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.

Trial Locations

Locations (92)

Norton Heart and Vascular Institute; 🇺🇸 Louisville, Kentucky, United States

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

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