Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release. The LEADR PAS is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).
The LEADR PAS is a global, prospective, observational, multi-site registry study. This study is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).
Eligibility for enrollment is based on market release dates for the OmniaSecure™ defibrillation lead within the geography in which the subject is enrolled.
Patients enrolled in LEADR PAS will be prospectively followed for the lifetime of device post-implant or until registry closure, patient death, or patient exit from the registry (i.e., withdrawal of consent).
Successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. The primary objective analysis will occur when 500 patients reach 5 years of follow-up. The total estimated registry duration is through lifetime of device.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| defibrillation lead | Device | This is a device registry for the OmniaSecure™ defibrillation lead. The OmniaSecure lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with a Right Ventricular (RV) defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies, and has application for patients whom transvenous ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated. |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Survival Rate | Estimate OmniaSecure lead-related complication-free survival through 5 years post implant. | 5 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Geographies with regulatory approval for the OmniaSecure™ defibrillation lead are eligible to enroll patients (see locations section). Any patient receiving an implant of the OmniaSecure lead, based on the treating physician's medical discretion, is eligible for enrollment into the study (patients previously enrolled in the pre-market clinical trial with a clinical model 093000 OmniaSecure lead may also be eligible for continued follow-up into the OmniaSecure PAS). In geographies where applicable, OmniaSecure PAS will include adolescent pediatric patients, who are at least 30 kg and are also at least 12 years of age, whose cardiac anatomy is conducive to RV coil placement.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| COR Healthcare |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Torrance |
| California |
| 90505- 5100 |
| United States |
| Childrens Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Hartford Hosptial | Hartford | Connecticut | 06106 | United States |
| Childrens National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Heart Rhythm Solutions | Hollywood | Florida | 33021 | United States |
| Cardiovascular Institute of Northwest Florida | Panama City | Florida | 32405 | United States |
| Heart & Vascular Institute of Florida | Safety Harbor | Florida | 34695 | United States |
| University of South Florida Health (USF) | Tampa | Florida | 33612 | United States |
| WellStar Research Institute | Marietta | Georgia | 30060 | United States |
| Deaconess Specialty Physicians | Newburgh | Indiana | 47630 | United States |
| Iowa Heart Center (West Des Moines IA) | West Des Moines | Iowa | 50266-8209 | United States |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160-8500 | United States |
| Saint Elizabeth Healthcare | Edgewood | Kentucky | 41017 | United States |
| Norton Heart and Vascular Institute | Louisville | Kentucky | 40205 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Metropolitan Cardiology Consultants | Coon Rapids | Minnesota | 55433-4568 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| M Health Fairview University of Minnesota Medical Center - East Bank | Minneapolis | Minnesota | 55455 | United States |
| North Memorial Health Heart & Vascular Center | Robbinsdale | Minnesota | 55422-4391 | United States |
| Mayo Clinic (Rochester MN) | Rochester | Minnesota | 55905 | United States |
| University Hospital (Columbia MO) | Columbia | Missouri | 65212 | United States |
| Saint Lukes Health System | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Virtua Health | Marlton | New Jersey | 08053 | United States |
| Presbyterian Heart Group | Albuquerque | New Mexico | 87106 | United States |
| Northwell Health South Shore University Hospital | Bay Shore | New York | 11706 | United States |
| Northwell Health Huntington Hospital | Huntington | New York | 11743-2787 | United States |
| Northwell Health North Shore University Hospital | New York | New York | 10075 | United States |
| Long Island Jewish Medical Center | New York | New York | 11040 | United States |
| Northwell Health Staten Island University Hospital | Staten Island | New York | 10305-3400 | United States |
| Duke University Medical Center (DUMC) | Durham | North Carolina | 27705-4699 | United States |
| WakeMed Health & Hospitals | Raleigh | North Carolina | 27610 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210-1252 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-9800 | United States |
| Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Saint Thomas Research Institute | Nashville | Tennessee | 37205 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Consultants in Cardiology (Fort Worth TX) | Fort Worth | Texas | 76104 | United States |
| Heart Center of North Texas | Fort Worth | Texas | 76104 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53215 | United States |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) | Québec | Quebec | G1V4G5 | Canada |
| OC Santé - Clinique du Millénaire | Montpellier | 34960 | France |
| Hospital Universitario Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided