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Lead survivability will be summarized.
The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
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| Measure | Description | Time Frame |
|---|---|---|
| Model 4396 LV Lead-related complication rate | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Types of lead-related adverse device effects | 5 years | |
| Percent of subjects with changes in electrode programming | 5 years | |
| Number of fractures with and without loss of function |
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Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
Inclusion Criteria
Exclusion Criteria
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Patients implanted with a 4396 LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest EP Clinic | Gilbert | Arizona | 85295 | United States | ||
| Saint Vincent Heart Clinic Arkansas |
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| 5 years |
| Bipolar electrical performance at 1 year | 1 year |
| Bipolar pacing impedance | 1 year |
| Bipolar pacing capture threshold | 1 year |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Eisenhower Desert Cardiology Center | Rancho Mirage | California | 92270 | United States |
| COR Healthcare | Torrance | California | 90503 | United States |
| Cardiovascular Consultants Medical Group | Van Nuys | California | 91405 | United States |
| Colorado Heart and Vascular, PC | Lakewood | Colorado | 80228 | United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| MedStar Southern Maryland Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Bradenton Cardiology | Bradenton | Florida | 34205 | United States |
| Baptist Heart Specialists | Jacksonville | Florida | 32216 | United States |
| Indiana University Health - Methodist Research Institute | Indianapolis | Indiana | 46202 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Louisville Cardiology Group | Louisville | Kentucky | 40207 | United States |
| Cenla Heart Specialists | Alexandria | Louisiana | 71301 | United States |
| Our Lady of the Lake Office of Research | Baton Rouge | Louisiana | 70808 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Metropolitan Cardiology Consultants PA | Coon Rapids | Minnesota | 55433 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| North Memorial Heart and Vascular Institute | Robbinsdale | Minnesota | 55422 | United States |
| HealthCare Partners Medical Group | Saint Louis Park | Minnesota | 55416 | United States |
| Saint Lukes Health System | Kansas City | Missouri | 64111 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Patients First Health Care LLC | Washington | Missouri | 63090 | United States |
| New Jersey Cardiology Associates | West Orange | New Jersey | 07052 | United States |
| Presbyterian Heart Group | Albuquerque | New Mexico | 87106 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| New York-Presbyterian Hospital/Columbia University Medical Center | New York | New York | 10032 | United States |
| New York-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Central New York Cardiology | Utica | New York | 13501 | United States |
| WakeMed Health & Hospitals | Raleigh | North Carolina | 27610 | United States |
| The Christ Hospital Health Network | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Lehigh Valley Health Network | Bethlehem | Pennsylvania | 18017 | United States |
| Medicor Associates | Erie | Pennsylvania | 16507 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17603 | United States |
| Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
| Saint Thomas Research Institute | Nashville | Tennessee | 37205 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Baylor Research Institute | Dallas | Texas | 75206 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Baylor Research Institute | Plano | Texas | 75093 | United States |
| STAR Clinical Trials | San Antonio | Texas | 78229 | United States |
| EP Heart LLC | The Woodlands | Texas | 77384 | United States |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53215 | United States |
| Queen's University & Kingston General Hospital | Kingston | Ontario | K7L 3N6 | Canada |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Hopital Hotel-Dieu | Montreal | Quebec | H2W 1T8 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) | Québec | G1V 4G5 | Canada |
| Universitatsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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