Personalized CRT - Product Surveillance Registry (PSR)

Medtronic0 sites1,517 target enrollmentJanuary 2012

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Medtronic
Enrollment: 1517
Primary Endpoint: CRT Response
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

April 28, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medtronic

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

CRT Response

Time Frame: 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 Outcomes

Treatment effects for different CRT features in the CRT non-responder population(Every 3-9 months)
Patient outcome post initial CRT implant(Every 3-9 months)
Treatments for CRT non-response(Every 3-9 months)