Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Rhone Durance, Avignon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

Observational only without any intervention

Primary outcomes

positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure

Time frame: Up to 5 years

To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure

Secondary outcomes

Number of HF hospitalization or HF related deaths

Time frame: Up to 5 years

Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2028
First posted: Jul 28, 2020
Registry last updated: Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting