The Product Surveillance Registry REVERSE Post Approval Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/27/2018 |
| Start Date: | April 2012 |
| End Date: | April 2021 |
| Contact: | Medtronic Product Surveillance Registry |
| Email: | rs.productsurveillanceregistry@medtronic.com |
| Phone: | 8006338766 |
The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study
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.
the REVERSE and RAFT pivotal studies in "real-world" clinical practice.
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.
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.
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 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
We found this trial at
125
sites
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