Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study

Details

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.

Keywords

Heart Failure

Eligibility

You can join if…

  • 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

You CAN'T join if...

  • 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

Locations

  • San Francisco California 94143 United States
  • Redwood City California 94062 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic
ID
NCT01660035
Study Type
Observational
Last Updated