Personalized CRT - MPP Post Approval Study

Completed

Conditions studied: Heart Failure

In brief

The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).

Key facts

Study ID

NCT03232944

Run by

Medtronic

People needed

1338

Starts

2017-07-05

Expected to finish

2021-01-07

Last updated by the study team

2021-02-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Saint Vincent Heart Clinic Arkansas — Little Rock, Arkansas, United States
• Chula Vista Cardiac Center — Chula Vista, California, United States
• Desert Heart Rhythm Consultants — Palm Springs, California, United States
• COR Healthcare — Torrance, California, United States
• Colorado Springs Cardiology — Colorado Springs, Colorado, United States
• Denver Heart — Denver, Colorado, United States
• Colorado Heart and Vascular, PC — Lakewood, Colorado, United States
• Heart Rhythm Solutions — Hollywood, Florida, United States
• Baptist Health — Jacksonville, Florida, United States
• Heart & Vascular Institute of Florida — Safety Harbor, Florida, United States
• Phoebe Putney Memorial Hospital — Albany, Georgia, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• MedStar Health Research Institute — Baltimore, Maryland, United States
• The Johns Hopkins Hospital — Bethesda, Maryland, United States
• Delmarva Heart Research Foundation Inc — Salisbury, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• UP Health System - Marquette — Marquette, Michigan, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• North Memorial Heart and Vascular Institute — Robbinsdale, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Missouri Cardiovascular Specialists — Columbia, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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