The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

Inclusion Criteria

• •1. Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:
• •* Chronic and/or permanent atrial fibrillation with 2° or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or
• •* Normal sinus rhythm with 2° or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
• •* Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
• •2. Subject is ≥18 years of age; and
• •3. Subject has a life expectancy of at least one year; and
• •4. Subject is not enrolled in another clinical investigation; and
• •5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
• •6. Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and
• •7. Subject is not pregnant and does not plan to get pregnant during the course of the study.