Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic
- Enrollment
- 2200
- Locations
- 92
- Primary Endpoint
- positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
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(Up to 5 years)