Bradycardia Clinical Trial
— REASSURE RegOfficial title:
Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
| Status | Completed |
| Enrollment | 157 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol - Patient is implanted with an investigational B301 device as part of the REASSURE AV study Exclusion Criteria: * None |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Abington Memorial Hospital | Abington | Pennsylvania |
| United States | Alaska Heart Institute | Anchorage | Alaska |
| United States | Piedmont Hospital | Atlanta | Georgia |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Deborah Heart and Lung Center | Browns Mills | New Jersey |
| United States | Lahey Clinic Medical Center | Burlington | Massachusetts |
| United States | Christ Hospital - Cincinnati | Cincinnati | Ohio |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Ohio State University Medical Center | Columbus | Ohio |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | Mercy Hospital Medical Center | Des Moines | Iowa |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Good Samaritan Hospital | Downers Grove | Illinois |
| United States | Saint Mary's Duluth Clinic | Duluth | Minnesota |
| United States | Inova Fairfax Hospital | Fairfax | Virginia |
| United States | St. Mary Medical Center | Hobart | Indiana |
| United States | Center For Cardiac Arrhythmias | Houston | Texas |
| United States | Northern California Heart Care | Larkspur | California |
| United States | Sunrise Hospital & Medical Center | Las Vegas | Nevada |
| United States | Central Baptist Hospital | Lexington | Kentucky |
| United States | Louisville Cardiology Medical Group | Louisville | Kentucky |
| United States | Medical Center Cardiologist Research | Louisville | Kentucky |
| United States | Heart Care Research Foundation | Merrionette Park | Illinois |
| United States | Ochsner Foundation Hospital | New Orleans | Louisiana |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Orlando Regional Hospital | Orlando | Florida |
| United States | Owensboro Mercy Health System | Owensboro | Kentucky |
| United States | Chippenham Medical Center | Richmond | Virginia |
| United States | St. Joseph Hospital | Savannah | Georgia |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | St. Anthony's Medical Center | St. Louis | Missouri |
| United States | Heart and Vascular Institute | St. Petersburg | Florida |
| United States | Hillcrest Medical Center | Tulsa | Oklahoma |
| United States | Reading Hospital and Medical Center | West Reading | Pennsylvania |
| United States | University of Massachusetts | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidences of ventricular shock therapy | There are no statistical endpoints for this registry. Incidences of ventricular shock therapy and their suspected causes and outcome will be the primary focus of this registry. | Report annually | Yes |
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