Personalized CRT - PSR

Completed

• Conditions: Heart Failure

• Registration Number: NCT03723265
• Lead Sponsor: Medtronic

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-29
• Primary Completion: 2022-04-28
• Study Completion: 2022-04-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1517

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRT Response	Every 3-9 months	A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response for all patients from baseline to follow-up visits.

Secondary Outcome Measures

Name	Time	Method
Treatment effects for different CRT features in the CRT non-responder population	Every 3-9 months	A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response.
Patient outcome post initial CRT implant	Every 3-9 months	Patient outcome will be measured as the patient first occurrence of HF related hospitalization or death.
Treatments for CRT non-response	Every 3-9 months	Summary statistics will be obtained to describe the distribution of different treatments (or no treatment) the patient receives.