Personalized CRT - MPP Post Approval Study

NCT ID: NCT03232944

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1338 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-05
• Study Completion Date: 2021-01-07

Brief Summary

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).

Detailed Description

Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities receiving appropriate license or regulatory approval during the conduct of the PAS were included and contributed to the PAS objectives upon commercial release. CRT is an established pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized biventricular (BiV) pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced event, both ventricles are stimulated to synchronize their contraction. The MPP feature is designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either before or after the LV paces, with the order determined by the programmed Ventricular Pacing Configuration.

The MPP PAS was a global, prospective, observational multi-center study. Patients implanted with an eligible CRT Quad system were enrolled and followed in the Product Surveillance Registry per the expected standard of care practices of their care provider.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CRT non-responders with MPP enabled

Patients enrolled and implanted with a CRT Quad system, who are identified as CRT non-responder, for which MPP is enabled.

Cardiac Resynchronization Therapy - MPP

Intervention Type: DEVICE

The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.

Interventions

Cardiac Resynchronization Therapy - MPP

The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.

Intervention Type: DEVICE

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 is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

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

HealthCare Partners Medical Group

Henderson, Nevada, United States

Presbyterian Heart Group

Albuquerque, New Mexico, United States

Island Cardiac Specialists

Garden City, New York, United States

Huntington Hospital

Huntington, New York, United States

Northwell Health

Manhasset, New York, United States

Hudson Valley Heart Center

Poughkeepsie, New York, United States

Central New York Cardiology

Utica, New York, United States

WakeMed Health & Hospitals

Raleigh, North Carolina, United States

Northeast Ohio Cardiovascular Specialists

Akron, Ohio, United States

The Christ Hospital Health Network

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Mercy Health - Saint Vincent Medical Center

Toledo, Ohio, United States

Cleveland Clinic

Cleveland, Oklahoma, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Saint Thomas Research Institute

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

The University of Vermont Medical Center

Burlington, Vermont, United States

Kootenai Heart Clinics Northwest

Spokane, Washington, United States

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

UZ Leuven - Campus Gasthuisberg

Leuven, , Belgium

CHU UCL Mont-Godinne - Dinant

Yvoir, , Belgium

Montreal Heart Institute

Montreal, Quebec, Canada

Institut de cardiologie et de pneumologie de Québec (IUCPQ)

Québec, Quebec, Canada

CHRU Brest - Hôpital de la Cavale Blanche

Brest, , France

Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

Clermont-Ferrand, , France

CHRU La Rochelle

La Rochelle, , France

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, , France

Nouvelles Cliniques Nantaises

Nantes, , France

Centre hospitalier de la région d'Annecy

Pringy, , France

Universitätsklinikum Aachen, AöR

Aachen, , Germany

St. Vinzenz-Hospital Köln

Cologne, , Germany

Universitätsklinikum Essen

Essen, , Germany

Universitätsklinikum des Saarlandes

Homburg, , Germany

Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen

Tübingen, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Magyar Honvédség Honvédkorház

Budapest, , Hungary

Azienda Ospedaliera Ospedale Niguarda Cà Granda

Milan, , Italy

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, , Malaysia

Maastricht Universitair Medisch Centrum

Maastricht, , Netherlands

Maasstad Hospital Rotterdam

Rotterdam, , Netherlands

Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

Košice, , Slovakia

Samsung Medical Center

Seoul, , South Korea

Hospital Universitario da Coruña

A Coruña, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Universitario Son Espases

Palma de Mallorca, , Spain

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, , Spain

University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, , United Kingdom

Glenfield Hospital

Leicester, , United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, , United Kingdom

Central Manchester University Hospitals NHS - Manchester Royal Infirmary

Manchester, , United Kingdom

The James Cook University Hospital - South Tees Hospitals NHS

Middlesbrough, , United Kingdom

Countries

United States; Belgium; Canada; France; Germany; Hungary; Italy; Malaysia; Netherlands; Slovakia; South Korea; Spain; United Kingdom

Other Identifiers

MPP PAS

Identifier Type: -

Identifier Source: org_study_id