Personalized CRT - MPP Post Approval Study

NCT03232944 | Completed

• 1 other identifier: MPP PAS
• Study Type: observational
• Target: 1,338
• Locations: 13 countries
• Sites: 78

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• MPP therapy responder

  To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed "on".

  Up to 3 years

Secondary Outcomes (1)

• HF hospitalization and/or mortality

  Up to 3 years

Study Arms (1)

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.

Device: Cardiac Resynchronization Therapy - MPP

Interventions

Cardiac Resynchronization Therapy - MPP DEVICE

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

CRT non-responders with MPP enabled

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients that are or will be implanted with an eligible CRT Quad system.

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

Sponsors & Collaborators

• Medtronic: lead

Study Sites (78)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0001, United States

Location

Saint Vincent Heart Clinic Arkansas

Little Rock, Arkansas, 72205-6202, United States

Location

Chula Vista Cardiac Center

Chula Vista, California, 91910, United States

Location

Desert Heart Rhythm Consultants

Palm Springs, California, 92262, United States

Location

COR Healthcare

Torrance, California, 90505, United States

Location

Colorado Springs Cardiology

Colorado Springs, Colorado, 80907, United States

Location

Denver Heart

Denver, Colorado, 80204, United States

Location

Colorado Heart and Vascular, PC

Lakewood, Colorado, 80228, United States

Location

Heart Rhythm Solutions

Hollywood, Florida, 33021, United States

Location

Baptist Health

Jacksonville, Florida, 32207, United States

Location

Heart & Vascular Institute of Florida

Safety Harbor, Florida, 34695-6604, United States

Location

Phoebe Putney Memorial Hospital

Albany, Georgia, 31701, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160-8500, United States

Location

MedStar Health Research Institute

Baltimore, Maryland, 21237-3958, United States

Location

The Johns Hopkins Hospital

Bethesda, Maryland, 20817, United States

Location

Delmarva Heart Research Foundation Inc

Salisbury, Maryland, 21804-6938, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2621, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

UP Health System - Marquette

Marquette, Michigan, 49855-2705, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197-8633, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407-1157, United States

Location

North Memorial Heart and Vascular Institute

Robbinsdale, Minnesota, 55422, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Missouri Cardiovascular Specialists

Columbia, Missouri, 65201-8023, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

HealthCare Partners Medical Group

Henderson, Nevada, 89052-4171, United States

Location

Presbyterian Heart Group

Albuquerque, New Mexico, 87106-4921, United States

Location

Island Cardiac Specialists

Garden City, New York, 11530-1613, United States

Location

Huntington Hospital

Huntington, New York, 11743-2787, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Hudson Valley Heart Center

Poughkeepsie, New York, 12601-3923, United States

Location

Central New York Cardiology

Utica, New York, 13501-5930, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

Location

Northeast Ohio Cardiovascular Specialists

Akron, Ohio, 44304-1473, United States

Location

The Christ Hospital Health Network

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0542, United States

Location

Mercy Health - Saint Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Cleveland Clinic

Cleveland, Oklahoma, 44195-0001, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103-6381, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Saint Thomas Research Institute

Nashville, Tennessee, 37205-2018, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705-1852, United States

Location

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Kootenai Heart Clinics Northwest

Spokane, Washington, 99204-2352, United States

Location

Aurora Cardiovascular Services

Milwaukee, Wisconsin, 53215, United States

Location

UZ Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

CHU UCL Mont-Godinne - Dinant

Yvoir, 5530, Belgium

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Institut de cardiologie et de pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

CHRU Brest - Hôpital de la Cavale Blanche

Brest, 29609, France

Location

Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

Clermont-Ferrand, 63003, France

Location

CHRU La Rochelle

La Rochelle, 17019, France

Location

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Nouvelles Cliniques Nantaises

Nantes, 44277, France

Location

Centre hospitalier de la région d'Annecy

Pringy, 74374, France

Location

Universitätsklinikum Aachen, AöR

Aachen, 52074, Germany

Location

St. Vinzenz-Hospital Köln

Cologne, 50733, Germany

Location

Universitätsklinikum Essen

Essen, 045147, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Magyar Honvédség Honvédkorház

Budapest, 1134, Hungary

Location

Azienda Ospedaliera Ospedale Niguarda Cà Granda

Milan, 20162, Italy

Location

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, 50400, Malaysia

Location

Maastricht Universitair Medisch Centrum

Maastricht, 6229 HX, Netherlands

Location

Maasstad Hospital Rotterdam

Rotterdam, 3079 DZ, Netherlands

Location

Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

Košice, 04011, Slovakia

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Hospital Universitario da Coruña

A Coruña, 15006, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, 07210, Spain

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

Location

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, L14 3PE, United Kingdom

Location

Central Manchester University Hospitals NHS - Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

The James Cook University Hospital - South Tees Hospitals NHS

Middlesbrough, TS4 3BW, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 28, 2017
• Study Start: July 5, 2017
• Primary Completion: June 4, 2020
• Study Completion: January 7, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

ES (4); US (46); FR (6); CA (2); HU (1); MY (1); NL (2); GB (5); BE (2); SL (1); KR (1); IT (1); DE (6)