The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
prospective, non-randomized, multi-center, international clinical study is designed to
 confirm the safety and effectiveness of the Aveir LP System in a subject population indicated
 for a VVI(R) pacemaker.
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.

 Exclusion Criteria:

 1. Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop
 in arterial blood pressure with the onset of ventricular pacing; or

 2. Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate
 (DSP);

 3. Subject has a mechanical tricuspid valve prosthesis; or

 4. Subject has a pre-existing endocardial pacing or defibrillation leads; or

 5. Subject has current implantation of either conventional or subcutaneous implantable
 cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or

 6. Subject has an implanted vena cava filter; or

 7. Subject has evidence of thrombosis in one of the veins used for access during the
 procedure; or

 8. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of
 enrollment; or

 9. Subject has an implanted leadless cardiac pacemaker