REASSURE AV Registry
- Conditions
- BradycardiaSudden Cardiac Death
- Interventions
- Device: AV Therapy Assessment-B301 investigational device
- Registration Number
- NCT01074034
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
- Detailed Description
The Guidant ASSURE device is a fully featured pacemaker with additional atrial and ventricular tachyarrhythmia therapy features. The REASSURE AV study is a clinical evaluation to support approval of these features. This clinical study is intended to provide adequate performance data on two atrial tachyarrhythmia management features, namely the ATS and atrial ATP. In addition data will be collected to verify that the ventricular tachyarrhythmia rescue shock feature performs as intended in the clinical setting in combination with other pacemaker functions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
- 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
* None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AV Therapy Assessment group AV Therapy Assessment-B301 investigational device appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device
- Primary Outcome Measures
Name Time Method Inappropriate Shock Free Rate Three months post-implant Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.
- Secondary Outcome Measures
Name Time Method Conversion Success Rate up to Three Months Post-implant Three months post-implant For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.
Trial Locations
- Locations (36)
Owensboro Mercy Health System
🇺🇸Owensboro, Kentucky, United States
Center For Cardiac Arrhythmias
🇺🇸Houston, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Inova Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
Chippenham Medical Center
🇺🇸Richmond, Virginia, United States
Sunrise Hospital & Medical Center
🇺🇸Las Vegas, Nevada, United States
Christ Hospital - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Alaska Heart Institute
🇺🇸Anchorage, Alaska, United States
Northern California Heart Care
🇺🇸Larkspur, California, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Heart and Vascular Institute
🇺🇸Saint Petersburg, Florida, United States
St. Joseph Hospital
🇺🇸Savannah, Georgia, United States
Good Samaritan Hospital
🇺🇸Downers Grove, Illinois, United States
St. Mary Medical Center
🇺🇸Hobart, Indiana, United States
Heart Care Research Foundation
🇺🇸Merrionette Park, Illinois, United States
Mercy Hospital Medical Center
🇺🇸Des Moines, Iowa, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Ochsner Foundation Hospital
🇺🇸New Orleans, Louisiana, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Saint Mary's Duluth Clinic
🇺🇸Duluth, Minnesota, United States
St. Anthony's Medical Center
🇺🇸Saint Louis, Missouri, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Hillcrest Medical Center
🇺🇸Tulsa, Oklahoma, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸West Reading, Pennsylvania, United States
Orlando Regional Hospital
🇺🇸Orlando, Florida, United States
Medical Center Cardiologist Research
🇺🇸Louisville, Kentucky, United States
Louisville Cardiology Medical Group
🇺🇸Louisville, Kentucky, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States