Personalized CRT - MPP Post Approval Study

Personalized CRT - Multiple Point Pacing Post Approval Study

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy - MPP

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.

• Study Type: Observational
• Enrollment (Actual): 1338

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven - Campus Gasthuisberg
  • Yvoir, Belgium, 5530
    • CHU UCL Mont-Godinne - Dinant
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Québec, Quebec, Canada, G1V 4G5
      • Institut de cardiologie et de pneumologie de Québec (IUCPQ)
• France
  • Brest, France, 29609
    • CHRU Brest - Hôpital de la Cavale Blanche
  • Clermont-Ferrand, France, 63003
    • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
  • La Rochelle, France, 17019
    • CHRU La Rochelle
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Arnaud de Villeneuve
  • Nantes, France, 44277
    • Nouvelles Cliniques Nantaises
  • Pringy, France, 74374
    • Centre hospitalier de la région d'Annecy
• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen, AöR
  • Essen, Germany, 045147
    • Universitatsklinikum Essen
  • Homburg, Germany, 66421
    • Universitätsklinikum des Saarlandes
  • Köln, Germany, 50733
    • St. Vinzenz-Hospital Köln
  • Tübingen, Germany, 72076
    • Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
  • Ulm, Germany, 89081
    • Universitatsklinikum Ulm
• Hungary
  • Budapest, Hungary, 1134
    • Magyar Honvédség Honvédkorház
• Italy
  • Milano, Italy, 20162
    • Azienda Ospedaliera Ospedale Niguarda Ca Granda
• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • Institut Jantung Negara - National Heart Institute
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum
  • Rotterdam, Netherlands, 3079 DZ
    • Maasstad Hospital Rotterdam
• Slovakia
  • Kosice, Slovakia, 04011
    • Východoslovenský Ústav Srdcových A Cievnych Chorôb, A.S.
• Spain
  • A Coruña, Spain, 15006
    • Hospital Universitario da Coruna
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Palma de Mallorca, Spain, 07210
    • Hospital Universitario Son Espases
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago de Compostela
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
  • Leicester, United Kingdom, LE3 9QP
    • Glenfield Hospital
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • Manchester, United Kingdom, M13 9WL
    • Central Manchester University Hospitals NHS - Manchester Royal Infirmary
  • Middlesbrough, United Kingdom, TS4 3BW
    • The James Cook University Hospital - South Tees Hospitals NHS
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0001
      • University of Alabama at Birmingham
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-6202
      • Saint Vincent Heart Clinic Arkansas
  • California
    • Chula Vista, California, United States, 91910
      • Chula Vista Cardiac Center
    • Palm Springs, California, United States, 92262
      • Desert Heart Rhythm Consultants
    • Torrance, California, United States, 90505
      • COR Healthcare
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Cardiology
    • Denver, Colorado, United States, 80204
      • Denver Heart
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular, PC
  • Florida
    • Hollywood, Florida, United States, 33021
      • Heart Rhythm Solutions
    • Jacksonville, Florida, United States, 32207
      • Baptist Health
    • Safety Harbor, Florida, United States, 34695-6604
      • Heart & Vascular Institute of Florida
  • Georgia
    • Albany, Georgia, United States, 31701
      • Phoebe Putney Memorial Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160-8500
      • The University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21237-3958
      • MedStar Health Research Institute
    • Bethesda, Maryland, United States, 20817
      • The Johns Hopkins Hospital
    • Salisbury, Maryland, United States, 21804-6938
      • Delmarva Heart Research Foundation Inc
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114-2621
      • Massachusetts General Hospital
  • Michigan
    • Marquette, Michigan, United States, 49855-2705
      • UP Health System - Marquette
    • Ypsilanti, Michigan, United States, 48197-8633
      • Michigan Heart
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407-1157
      • Minneapolis Heart Institute Foundation
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Heart and Vascular Institute
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Columbia, Missouri, United States, 65201-8023
      • Missouri Cardiovascular Specialists
    • Saint Louis, Missouri, United States, 63110-1010
      • Washington University School of Medicine
  • Nevada
    • Henderson, Nevada, United States, 89052-4171
      • HealthCare Partners Medical Group
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106-4921
      • Presbyterian Heart Group
  • New York
    • Garden City, New York, United States, 11530-1613
      • Island Cardiac Specialists
    • Huntington, New York, United States, 11743-2787
      • Huntington Hospital
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • Poughkeepsie, New York, United States, 12601-3923
      • Hudson Valley Heart Center
    • Utica, New York, United States, 13501-5930
      • Central New York Cardiology
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Health & Hospitals
  • Ohio
    • Akron, Ohio, United States, 44304-1473
      • Northeast Ohio Cardiovascular Specialists
    • Cincinnati, Ohio, United States, 45267-0542
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital Health Network
    • Toledo, Ohio, United States, 43608
      • Mercy Health - Saint Vincent Medical Center
  • Oklahoma
    • Cleveland, Oklahoma, United States, 44195-0001
      • Cleveland Clinic
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103-6381
      • Lehigh Valley Health Network
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37205-2018
      • Saint Thomas Research Institute
  • Texas
    • Austin, Texas, United States, 78705-1852
      • Texas Cardiac Arrhythmia Research Foundation
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The University of Vermont Medical Center
  • Washington
    • Spokane, Washington, United States, 99204-2352
      • Kootenai Heart Clinics Northwest
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Cardiovascular Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HF hospitalization and/or mortality	Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled	Up to 3 years

Collaborators and Investigators

• Sponsor: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): June 4, 2020
• Study Completion (Actual): January 7, 2021

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MPP PAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No