The Product Surveillance Registry REVERSE Post Approval Study (PSR-REVERSE)

Medtronic

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT01660035

PSR-REVERSE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Volunteers: No Healthy Volunteers

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