Model 4396 Left Ventricular (LV) Lead Chronic Performance Study
Study Details
Study Description
Brief Summary
Lead survivability will be summarized.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Model 4396 LV Lead-related complication rate [5 years]
Secondary Outcome Measures
- 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 [5 years]
- Bipolar electrical performance at 1 year [1 year]
- Bipolar pacing impedance [1 year]
- Bipolar pacing capture threshold [1 year]
Eligibility Criteria
Criteria
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
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Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
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Patient has or is intended to receive an Attain Ability Model 4396 LV lead
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Patient within 30 day post implant enrollment window
Exclusion Criteria
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Patient who is, or is expected to be inaccessible for follow-up
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Patient with exclusion criteria required by local law
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Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Southwest EP Clinic | Gilbert | Arizona | United States | 85295 |
2 | Saint Vincent Heart Clinic Arkansas | Little Rock | Arkansas | United States | 72205 |
3 | Eisenhower Desert Cardiology Center | Rancho Mirage | California | United States | 92270 |
4 | COR Healthcare | Torrance | California | United States | 90503 |
5 | Cardiovascular Consultants Medical Group | Van Nuys | California | United States | 91405 |
6 | Colorado Heart and Vascular, PC | Lakewood | Colorado | United States | 80228 |
7 | Yale University | New Haven | Connecticut | United States | 06519 |
8 | MedStar Southern Maryland Hospital Center | Washington | District of Columbia | United States | 20010 |
9 | Bradenton Cardiology | Bradenton | Florida | United States | 34205 |
10 | Baptist Heart Specialists | Jacksonville | Florida | United States | 32216 |
11 | Indiana University Health - Methodist Research Institute | Indianapolis | Indiana | United States | 46202 |
12 | Iowa Heart Center | West Des Moines | Iowa | United States | 50266 |
13 | Louisville Cardiology Group | Louisville | Kentucky | United States | 40207 |
14 | Cenla Heart Specialists | Alexandria | Louisiana | United States | 71301 |
15 | Our Lady of the Lake Office of Research | Baton Rouge | Louisiana | United States | 70808 |
16 | Michigan Heart | Ypsilanti | Michigan | United States | 48197 |
17 | Metropolitan Cardiology Consultants PA | Coon Rapids | Minnesota | United States | 55433 |
18 | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | United States | 55407 |
19 | North Memorial Heart and Vascular Institute | Robbinsdale | Minnesota | United States | 55422 |
20 | HealthCare Partners Medical Group | Saint Louis Park | Minnesota | United States | 55416 |
21 | Saint Lukes Health System | Kansas City | Missouri | United States | 64111 |
22 | Washington University | Saint Louis | Missouri | United States | 63110 |
23 | Patients First Health Care LLC | Washington | Missouri | United States | 63090 |
24 | New Jersey Cardiology Associates | West Orange | New Jersey | United States | 07052 |
25 | Presbyterian Heart Group | Albuquerque | New Mexico | United States | 87106 |
26 | NYU Langone Medical Center | New York | New York | United States | 10016 |
27 | New York-Presbyterian Hospital/Columbia University Medical Center | New York | New York | United States | 10032 |
28 | New York-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | United States | 10065 |
29 | Central New York Cardiology | Utica | New York | United States | 13501 |
30 | WakeMed Health & Hospitals | Raleigh | North Carolina | United States | 27610 |
31 | The Christ Hospital Health Network | Cincinnati | Ohio | United States | 45219 |
32 | University of Cincinnati | Cincinnati | Ohio | United States | 45267 |
33 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
34 | Lehigh Valley Health Network | Allentown | Pennsylvania | United States | 18103 |
35 | Lehigh Valley Health Network | Bethlehem | Pennsylvania | United States | 18017 |
36 | Medicor Associates | Erie | Pennsylvania | United States | 16507 |
37 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17603 |
38 | Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
39 | Wellmont CVA Heart Institute | Kingsport | Tennessee | United States | 37660 |
40 | Saint Thomas Research Institute | Nashville | Tennessee | United States | 37205 |
41 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705 |
42 | Baylor Research Institute | Dallas | Texas | United States | 75206 |
43 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
44 | Baylor Research Institute | Plano | Texas | United States | 75093 |
45 | STAR Clinical Trials | San Antonio | Texas | United States | 78229 |
46 | EP Heart LLC | The Woodlands | Texas | United States | 77384 |
47 | The University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
48 | Aurora Cardiovascular Services | Milwaukee | Wisconsin | United States | 53215 |
49 | Queen's University & Kingston General Hospital | Kingston | Ontario | Canada | K7L 3N6 |
50 | Centre Hospitalier de l'Universite de Montreal (CHUM) Hopital Hotel-Dieu | Montreal | Quebec | Canada | H2W 1T8 |
51 | Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) | Quebec | Canada | G1V 4G5 | |
52 | Universitatsklinikum Ulm | Ulm | Baden-württemberg | Germany | 89081 |
Sponsors and Collaborators
- Medtronic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4396 Chronic Performance