Clinical Research Directory

Inclusion Criteria: * Life expectancy ≥ 2 years. * Indications for device implantation must be fulfilled per standard of care. Consistent with 2008 American College of Cardiology / American Heart Association guidelines for device therapy, one of the following class I indications must be met. * Sinus Node Dysfunction * Acquired Atrioventricular (AV) Block * Chronic Bifascicular Block * Hypersensitive Carotid Syndrome * Lack of financial ability to pay for a new device must be assessed and documented. * All other methods of new device acquisition must be exhausted. * Patient must be agreeable and able to follow-up with the implanting center within 2 weeks for wound check, at 2 months, 6 months, and every 6 months thereafter for routine pacemaker checks. Exclusion Criteria: * Severe valvular disease * Severe pulmonary disease * End-stage renal disease (creatinine clearance \< 30 mL/min) whether or not on dialysis * Evidence of ongoing systemic infection * Prior pacemaker or implantable cardioverter-defibrillator implantation * Significant contraindication to pacemaker implantation per evaluation of the implanting physician (very high risk of complications). * Presence of any other condition that the local investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period * Pregnant women