The Product Surveillance Registry REVERSE Post Approval Study

Completed

• Conditions: Heart Failure

• Registration Number: NCT01660035
• Lead Sponsor: Medtronic

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-08
• Status Verified: 2022-04
• Primary Completion: 2022-04
• Study Completion: 2022-04
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hattiesburg Clinic; 🇺🇸 Hattiesburg, Mississippi, United States