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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy - MPP | Device | The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes patients that are or will be implanted with an eligible CRT Quad system.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0001 | United States | ||
| Saint Vincent Heart Clinic Arkansas |
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| Little Rock |
| Arkansas |
| 72205-6202 |
| United States |
| Chula Vista Cardiac Center | Chula Vista | California | 91910 | United States |
| Desert Heart Rhythm Consultants | Palm Springs | California | 92262 | United States |
| COR Healthcare | Torrance | California | 90505 | United States |
| Colorado Springs Cardiology | Colorado Springs | Colorado | 80907 | United States |
| Denver Heart | Denver | Colorado | 80204 | United States |
| Colorado Heart and Vascular, PC | Lakewood | Colorado | 80228 | United States |
| Heart Rhythm Solutions | Hollywood | Florida | 33021 | United States |
| Baptist Health | Jacksonville | Florida | 32207 | United States |
| Heart & Vascular Institute of Florida | Safety Harbor | Florida | 34695-6604 | United States |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160-8500 | United States |
| MedStar Health Research Institute | Baltimore | Maryland | 21237-3958 | United States |
| The Johns Hopkins Hospital | Bethesda | Maryland | 20817 | United States |
| Delmarva Heart Research Foundation Inc | Salisbury | Maryland | 21804-6938 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2621 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| UP Health System - Marquette | Marquette | Michigan | 49855-2705 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197-8633 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407-1157 | United States |
| North Memorial Heart and Vascular Institute | Robbinsdale | Minnesota | 55422 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Missouri Cardiovascular Specialists | Columbia | Missouri | 65201-8023 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1010 | United States |
| HealthCare Partners Medical Group | Henderson | Nevada | 89052-4171 | United States |
| Presbyterian Heart Group | Albuquerque | New Mexico | 87106-4921 | United States |
| Island Cardiac Specialists | Garden City | New York | 11530-1613 | United States |
| Huntington Hospital | Huntington | New York | 11743-2787 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| Hudson Valley Heart Center | Poughkeepsie | New York | 12601-3923 | United States |
| Central New York Cardiology | Utica | New York | 13501-5930 | United States |
| WakeMed Health & Hospitals | Raleigh | North Carolina | 27610 | United States |
| Northeast Ohio Cardiovascular Specialists | Akron | Ohio | 44304-1473 | United States |
| The Christ Hospital Health Network | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267-0542 | United States |
| Mercy Health - Saint Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Cleveland Clinic | Cleveland | Oklahoma | 44195-0001 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103-6381 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Saint Thomas Research Institute | Nashville | Tennessee | 37205-2018 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705-1852 | United States |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Kootenai Heart Clinics Northwest | Spokane | Washington | 99204-2352 | United States |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53215 | United States |
| UZ Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| CHU UCL Mont-Godinne - Dinant | Yvoir | 5530 | Belgium |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Institut de cardiologie et de pneumologie de Québec (IUCPQ) | Québec | Quebec | G1V 4G5 | Canada |
| CHRU Brest - Hôpital de la Cavale Blanche | Brest | 29609 | France |
| Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied | Clermont-Ferrand | 63003 | France |
| CHRU La Rochelle | La Rochelle | 17019 | France |
| CHU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Nouvelles Cliniques Nantaises | Nantes | 44277 | France |
| Centre hospitalier de la région d'Annecy | Pringy | 74374 | France |
| Universitätsklinikum Aachen, AöR | Aachen | 52074 | Germany |
| St. Vinzenz-Hospital Köln | Cologne | 50733 | Germany |
| Universitätsklinikum Essen | Essen | 045147 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | 66421 | Germany |
| Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Magyar Honvédség Honvédkorház | Budapest | 1134 | Hungary |
| Azienda Ospedaliera Ospedale Niguarda Cà Granda | Milan | 20162 | Italy |
| Institut Jantung Negara - National Heart Institute | Kuala Lumpur | 50400 | Malaysia |
| Maastricht Universitair Medisch Centrum | Maastricht | 6229 HX | Netherlands |
| Maasstad Hospital Rotterdam | Rotterdam | 3079 DZ | Netherlands |
| Vychodoslovensky ustav srdcovych a cievnych chorob, a.s. | Košice | 04011 | Slovakia |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Hospital Universitario da Coruña | A Coruña | 15006 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | 07210 | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | B15 2GW | United Kingdom |
| Glenfield Hospital | Leicester | LE3 9QP | United Kingdom |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | L14 3PE | United Kingdom |
| Central Manchester University Hospitals NHS - Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| The James Cook University Hospital - South Tees Hospitals NHS | Middlesbrough | TS4 3BW | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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