Heart Failure
Conditions
Brief summary
The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in real-world clinical practice.
Detailed description
The REVERSE PAS will estimate the 3-year survival probability of freedom from heart failure hospitalization and heart failure events in patients implanted with a Medtronic CRT-D device who meet the expanded indication criteria with a QRS duration ≤ 150 ms.
Interventions
None listed
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 a Medtronic CRT-D who meets the expanded CRT-D indication criteria with a QRS ≤ 150ms * Patient within 30 days of implant
Exclusion criteria
* Patient who is, or will be, inaccessible for follow-up * Patient with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival from Heart Failure Hospitalization and All-Cause Mortality | 3 years | To estimate the 3-year survival probability of freedom from heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms. |
| Survival from Heart Failure Event and All-Cause Mortality | 3 years | To estimate the 3-year survival probability of freedom from heart failure event or all- cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms. |
Countries
Belgium, Canada, France, Germany, Italy, Netherlands, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed