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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03232944
Other study ID # MPP PAS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 5, 2017
Est. completion date January 7, 2021

Study information

Verified date February 2021
Source Medtronic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 1338
Est. completion date January 7, 2021
Est. primary completion date June 4, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Cardiac Resynchronization Therapy - MPP
The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.

Locations

Country Name City State
Belgium UZ Leuven - Campus Gasthuisberg Leuven
Belgium CHU UCL Mont-Godinne - Dinant Yvoir
Canada Montreal Heart Institute Montreal Quebec
Canada Institut de cardiologie et de pneumologie de Québec (IUCPQ) Québec Quebec
France 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
Germany Universitätsklinikum Aachen, AöR Aachen
Germany Universitätsklinikum Essen Essen
Germany Universitätsklinikum des Saarlandes Homburg
Germany St. Vinzenz-Hospital Köln Köln
Germany Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen Tübingen
Germany Universitätsklinikum Ulm Ulm
Hungary Magyar Honvédség Honvédkorház Budapest
Italy Azienda Ospedaliera Ospedale Niguarda Cà Granda Milano
Korea, Republic of Samsung Medical Center Seoul
Malaysia Institut Jantung Negara - National Heart Institute Kuala Lumpur
Netherlands Maastricht Universitair Medisch Centrum Maastricht
Netherlands Maasstad Hospital Rotterdam Rotterdam
Slovakia Vychodoslovensky ustav srdcovych a cievnych chorob, a.s. Kosice
Spain 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
United Kingdom 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 States Northeast Ohio Cardiovascular Specialists Akron Ohio
United States Phoebe Putney Memorial Hospital Albany Georgia
United States Presbyterian Heart Group Albuquerque New Mexico
United States Lehigh Valley Health Network Allentown Pennsylvania
United States Texas Cardiac Arrhythmia Research Foundation Austin Texas
United States MedStar Health Research Institute Baltimore Maryland
United States The Johns Hopkins Hospital Bethesda Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States The University of Vermont Medical Center Burlington Vermont
United States Chula Vista Cardiac Center Chula Vista California
United States The Christ Hospital Health Network Cincinnati Ohio
United States University of Cincinnati Cincinnati Ohio
United States Cleveland Clinic Cleveland Oklahoma
United States Colorado Springs Cardiology Colorado Springs Colorado
United States Missouri Cardiovascular Specialists Columbia Missouri
United States Geisinger Medical Center Danville Pennsylvania
United States Denver Heart Denver Colorado
United States Island Cardiac Specialists Garden City New York
United States HealthCare Partners Medical Group Henderson Nevada
United States Heart Rhythm Solutions Hollywood Florida
United States Huntington Hospital Huntington New York
United States Baptist Health Jacksonville Florida
United States The University of Kansas Medical Center Kansas City Kansas
United States Colorado Heart and Vascular, PC Lakewood Colorado
United States Saint Vincent Heart Clinic Arkansas Little Rock Arkansas
United States Northwell Health Manhasset New York
United States UP Health System - Marquette Marquette Michigan
United States Aurora Cardiovascular Services Milwaukee Wisconsin
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States Saint Thomas Research Institute Nashville Tennessee
United States Desert Heart Rhythm Consultants Palm Springs California
United States Hudson Valley Heart Center Poughkeepsie New York
United States WakeMed Health & Hospitals Raleigh North Carolina
United States North Memorial Heart and Vascular Institute Robbinsdale Minnesota
United States Mayo Clinic Rochester Minnesota
United States Heart & Vascular Institute of Florida Safety Harbor Florida
United States Washington University School of Medicine Saint Louis Missouri
United States Delmarva Heart Research Foundation Inc Salisbury Maryland
United States Kootenai Heart Clinics Northwest Spokane Washington
United States Mercy Health - Saint Vincent Medical Center Toledo Ohio
United States COR Healthcare Torrance California
United States Central New York Cardiology Utica New York
United States Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Michigan Heart Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Malaysia,  Netherlands,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 HF hospitalization and/or mortality Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled Up to 3 years
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