Heart Failure Clinical Trial
Official title:
Personalized CRT - Multiple Point Pacing Post Approval Study
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 |
Verified date | February 2021 |
Source | Medtronic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Medtronic |
United States, Belgium, Canada, France, Germany, Hungary, Italy, Korea, Republic of, Malaysia, Netherlands, Slovakia, Spain, United Kingdom,
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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