Status:
ACTIVE_NOT_RECRUITING
Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
Lead Sponsor:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
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 S...
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 devic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT04489225
Start Date
August 1 2020
End Date
January 31 2028
Last Update
October 20 2025
Active Locations (92)
Enter a location and click search to find clinical trials sorted by distance.
1
Southwest EP
Chandler, Arizona, United States, 85226
2
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States, 72205-6202
3
Chula Vista Cardiac Center
Chula Vista, California, United States, 91910
4
Cardiovascular Consultants Medical Group
Van Nuys, California, United States, 91405