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The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).
The Attain Stability Quad (ASQ) PAS is a multi-center, single arm, prospective observational study. However, in the US, retrospective enrollments from participants in the IDE study (IDE #G170020) are allowed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadripolar LV Lead | Device | The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is an active fixation quadripolar LV lead based on the Attain Performa lead family models (4298, 4398, and 4598). The lead incorporates an active fixation helix similar to the OUS commercialized Attain Stability bipolar LV lead (Model 20066/4796) which is designed to allow an implanter more options in lead location. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients without a lead- related event at 5 years post-implant | To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lead-related adverse device effects | The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product: • To summarize all Attain Stability Quad lead-related ADEs | 5 years |
| Number of explanted leads that have been returned |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes patients that are or will be implanted with a Model 4798 lead and a Medtronic CRT device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Heart | Anchorage | Alaska | 99508-4673 | United States | ||
| Southwest EP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39694452 | Derived | Yee R, Love CJ, Kaiser DW, Birgersdotter-Green U, Cha YM, Singh JP, Liu S, Zhang Y, Chung ES. Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms. J Card Fail. 2025 May;31(5):824-832. doi: 10.1016/j.cardfail.2024.11.011. Epub 2024 Dec 16. |
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The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product: • To summarize analysis results from explanted and returned Attain Stability Quad leads |
| 5 years |
| Chandler |
| Arizona |
| 85295-1680 |
| United States |
| Cardiology Associates of Northeast Arkansas | Jonesboro | Arkansas | 72410-4163 | United States |
| Saint Vincent Heart Clinic Arkansas | Little Rock | Arkansas | 72205-6202 | United States |
| Chula Vista Cardiac Center | Chula Vista | California | 91910 | United States |
| San Diego Arrhythmia Associates | San Diego | California | 92103 | United States |
| COR Healthcare | Torrance | California | 90505 | United States |
| Cardiovascular Consultants Medical Group (Van Nuys) | Van Nuys | California | 91405-3646 | United States |
| Cardiology Associates Medical Group | Ventura | California | 93003 | United States |
| Colorado Springs Cardiology | Colorado Springs | Colorado | 80907 | United States |
| Denver Heart | Denver | Colorado | 80220-3918 | United States |
| Colorado Heart and Vascular | Lakewood | Colorado | 80228 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06520-8017 | United States |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756-3356 | United States |
| Heart Rhythm Solutions | Hollywood | Florida | 33021 | United States |
| Baptist Health | Jacksonville | Florida | 32207 | United States |
| Cardiovascular Institute of Northwest Florida | Panama City | Florida | 32405 | United States |
| Heart & Vascular Institute of Florida | Safety Harbor | Florida | 34695-6604 | United States |
| Heart Rhythm Consultants P.A. (Sarasota Memorial Research) | Sarasota | Florida | 34233 | United States |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701-1943 | United States |
| Deaconess Specialty Physicians | Evansville | Indiana | 47710 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160-8500 | United States |
| Saint Elizabeth Healthcare | Edgewood | Kentucky | 41017 | United States |
| Norton Heart Specialists | Louisville | Kentucky | 40205-3373 | United States |
| Our Lady of the Lake Office of Research | Baton Rouge | Louisiana | 70808 | United States |
| MedStar Health Research Institute | Baltimore | Maryland | 21237-3958 | United States |
| Tidal Health Peninsula Regional | Salisbury | Maryland | 21804-6938 | United States |
| Associates in Cardiology PA | Silver Spring | Maryland | 20910-1265 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2621 | United States |
| Brigham & Women's Hospital (Boston, MA) | Boston | Massachusetts | 02115-6110 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| UP Health System - Marquette | Marquette | Michigan | 49855-2705 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197-8633 | 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 |
| University Hospital of Missouri | Columbia | Missouri | 65212 | United States |
| Saint Lukes Health System | Kansas City | Missouri | 64111-5934 | United States |
| Washington University | St Louis | Missouri | 63110-1010 | United States |
| Nebraska Medicine | Omaha | Nebraska | 68105 | United States |
| Monmouth Cardiology Associates | Ocean City | New Jersey | 07712-4762 | United States |
| Presbyterian Heart Group | Albuquerque | New Mexico | 87106-4921 | United States |
| South Shore University Hospital | Bay Shore | New York | 11706 | United States |
| Huntington Hospital | Huntington | New York | 11743 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| New York-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10021 | United States |
| New York-Presbyterian Hospital/Columbia University Medical Center | New York | New York | 10032 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Hudson Valley Heart Center | Poughkeepsie | New York | 12601-3923 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305-3436 | United States |
| Duke University Medical Center (DUMC) | Durham | North Carolina | 27705 | United States |
| WakeMed Health & Hospitals | Raleigh | North Carolina | 27610 | United States |
| Summa Center for Clinical Trials-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 |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015-1155 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| UPMC Heart and Vascular Institute at UPMC Hamot | Erie | Pennsylvania | 16507-1579 | United States |
| Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Saint Thomas Research Institute | Nashville | Tennessee | 37205-2018 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8802 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705-1852 | United States |
| Heart Center of North Texas | Fort Worth | Texas | 761014 | United States |
| Consultants in Cardiology | Fort Worth | Texas | 76104-2821 | United States |
| EP Heart | The Woodlands | Texas | 77384 | United States |
| Kootenai Heart Clinics Northwest | Spokane | Washington | 99204-2352 | United States |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53215 | United States |
| Clinique Rhône Durance | Avignon | 84082 | France |
| Centre Hospitalier de la Côte Basque | Bayonne | 64109 | France |
| CHRU Brest - Hôpital de la Cavale Blanche | Brest | 29609 | France |
| Générale de Santé - Hôpital Privé Saint Martin | Caen | 14000 | France |
| CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol | Caen | 14033 | France |
| CHU de Clermont Ferrand | Clermont-Ferrand | 63003 | France |
| CHU de Dijon - Hospital Le Bocage | Dijon | 21079 | France |
| CHRU La Rochelle | La Rochelle | 17019 | France |
| Hopital prive Clairval - Ramsay Sante | Marseille | 13009 | France |
| Nouvelles Cliniques Nantaises | Nantes | France |
| Centre hospitalier de la région d'Annecy | Pringy | 74374 | France |
| Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Capio - Clinique du Tonkin | Villeurbanne | 69100 | France |
| Hygeia Hospital | Athens | 15123 | Greece |
| Athens Medical Center | Marousi | 15125 | Greece |
| Policlinico Sant' Orsola - Malpighi | Bologna | 40138 | Italy |
| Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari" | Castrovillari | 87012 | Italy |
| Ospedale "Vito Fazzi" Lecce | Lecce | 73100 | Italy |
| Azienda Ospedaliera Ospedale Niguarda Ca Granda | Milan | 20162 | Italy |
| Presidio Ospedaliero Centrale - SS. Annunziata | Taranto | 74024 | Italy |
| Azienda ospedaleria Santa Maria della Misericordia di Udine | Udine | Italy |
| Hospital da Senhora da Oliveira - Guimarães | Guimarães | 4835-044 | Portugal |
| Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar Universitário de São João | Porto | 4200-319 | Portugal |
| Hospital Distrital de Santarém | Santarém | 2000-177 | Portugal |
| Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.) | Bratislava | Slovakia |
| Hospital Universitario da Coruna | A Coruña | 15006 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Universitario Clínico San Cecilio | Granada | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Complejo Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47006 | Spain |
| Hôpitaux Universitaires de Genève | Geneva | 1205 | Switzerland |
| Cardiopark Zurich | Zurich | 8027 | Switzerland |
| University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | United Kingdom |
| Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital | Blackpool | United Kingdom |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | United Kingdom |
| Imperial College Healthcare NHS Trust - Hammersmith Hospital | London | United Kingdom |
| Central Manchester University Hospitals NHS - Manchester Royal Infirmary | Manchester | United Kingdom |
| The James Cook University Hospital - South Tees Hospitals NHS | Middlesbrough | United Kingdom |
| Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General | Sheffield | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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