Heart Failure
Conditions
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.
Interventions
OTHERObservational
Observational only without any intervention
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France, Greece, Italy, Portugal, Slovakia, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed