Trials / Completed
CompletedNCT01660035
The Product Surveillance Registry REVERSE Post Approval Study
The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 155 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2022-04-01
- Completion
- 2022-04-01
- First posted
- 2012-08-08
- Last updated
- 2022-04-18
Locations
123 sites across 10 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01660035. Inclusion in this directory is not an endorsement.