Personalized CRT - MPP Post Approval Study
- Conditions
- Heart Failure
- Interventions
- Device: Cardiac Resynchronization Therapy - MPP
- Registration Number
- NCT03232944
- Lead Sponsor
- Medtronic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1338
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CRT non-responders with MPP enabled Cardiac Resynchronization Therapy - MPP Patients enrolled and implanted with a CRT Quad system, who are identified as CRT non-responder, for which MPP is enabled.
- Primary Outcome Measures
Name Time Method MPP therapy responder Up to 3 years To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed "on".
- Secondary Outcome Measures
Name Time Method HF hospitalization and/or mortality Up to 3 years Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled
Trial Locations
- Locations (78)
COR Healthcare
🇺🇸Torrance, California, 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
MedStar Health Research Institute
🇺🇸Baltimore, Maryland, United States
Missouri Cardiovascular Specialists
🇺🇸Columbia, Missouri, United States
Colorado Heart and Vascular, PC
🇺🇸Lakewood, Colorado, United States
Hudson Valley Heart Center
🇺🇸Poughkeepsie, New York, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Colorado Springs Cardiology
🇺🇸Colorado Springs, Colorado, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
CHU UCL Mont-Godinne - Dinant
🇧🇪Yvoir, Belgium
Presbyterian Heart Group
🇺🇸Albuquerque, New Mexico, United States
Universitätsklinikum Aachen, AöR
🇩🇪Aachen, Germany
Delmarva Heart Research Foundation Inc
🇺🇸Salisbury, Maryland, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
CHRU Brest - Hôpital de la Cavale Blanche
🇫🇷Brest, France
Mercy Health - Saint Vincent Medical Center
🇺🇸Toledo, Ohio, United States
UZ Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
CHRU La Rochelle
🇫🇷La Rochelle, France
UP Health System - Marquette
🇺🇸Marquette, Michigan, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
🇸🇰Kosice, Slovakia
CHU de Montpellier - Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Magyar Honvédség Honvédkorház
🇭🇺Budapest, Hungary
HealthCare Partners Medical Group
🇺🇸Henderson, Nevada, United States
Hospital Universitario da Coruña
🇪🇸A Coruña, Spain
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Kootenai Heart Clinics Northwest
🇺🇸Spokane, Washington, United States
Central New York Cardiology
🇺🇸Utica, New York, United States
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Spain
Azienda Ospedaliera Ospedale Niguarda Cà Granda
🇮🇹Milano, Italy
Universitätsklinikum Essen
🇩🇪Essen, Germany
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Institut Jantung Negara - National Heart Institute
🇲🇾Kuala Lumpur, Malaysia
Cleveland Clinic
🇺🇸Cleveland, Oklahoma, United States
Complejo Hospitalario Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
The James Cook University Hospital - South Tees Hospitals NHS
🇬🇧Middlesbrough, United Kingdom
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Maastricht Universitair Medisch Centrum
🇳🇱Maastricht, Netherlands
Maasstad Hospital Rotterdam
🇳🇱Rotterdam, Netherlands
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Institut de cardiologie et de pneumologie de Québec (IUCPQ)
🇨🇦Québec, Quebec, Canada
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Baptist Health
🇺🇸Jacksonville, Florida, United States
Heart & Vascular Institute of Florida
🇺🇸Safety Harbor, Florida, United States
Heart Rhythm Solutions
🇺🇸Hollywood, Florida, United States
Phoebe Putney Memorial Hospital
🇺🇸Albany, Georgia, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Huntington Hospital
🇺🇸Huntington, New York, United States
Island Cardiac Specialists
🇺🇸Garden City, 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
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
The University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
🇫🇷Clermont-Ferrand, France
Centre hospitalier de la région d'Annecy
🇫🇷Pringy, France
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
St. Vinzenz-Hospital Köln
🇩🇪Köln, Germany
North Memorial Heart and Vascular Institute
🇺🇸Robbinsdale, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Saint Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Johns Hopkins Hospital
🇺🇸Bethesda, Maryland, United States
Denver Heart
🇺🇸Denver, Colorado, United States
Aurora Cardiovascular Services
🇺🇸Milwaukee, Wisconsin, United States