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

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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 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.

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
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Charlotte, North Carolina 28207
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Colorado Springs, Colorado 80910
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