Personalized CRT - PSR

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: Cardiac Resynchronization Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT03723265

Personalized CRT

Details and patient eligibility

About

The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

Full description

The Personalized CRT study is a multi-center, single arm, prospective observational study. The purpose of the study is to better understand and characterize heart failure (HF) patient management by characterizing the use and clinical benefit of Medtronic market-released features/tools within the HF Patient Management portfolio.

Enrollment: 1,517 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 an eligible CRT device
• Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

Exclusion criteria

• Patient who is, or is expected to 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