Trials / Active Not Recruiting
Active Not RecruitingNCT04489225
Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,200 (estimated)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational | Observational only without any intervention |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2024-12-06
- Completion
- 2028-01-31
- First posted
- 2020-07-28
- Last updated
- 2025-10-20
Locations
92 sites across 9 countries: United States, France, Greece, Italy, Portugal, Slovakia, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT04489225. Inclusion in this directory is not an endorsement.