The LEADLESS II Study - A safety and effectiveness trial for a leadless pacemaker system

Trial ID:
IRB-14-6347
Steven Higgins
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness investigation.

Inclusion Criteria:

  • 1. Subject must have one of the clinical indications 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 ≥18 years of age; and
  • 3. Subject has 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 written informed consent, approved by the IRB; and
  • 7. Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion Criteria:

  • 1. Subject has 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; or
  • 3. Subject has a mechanical tricuspid valve prosthesis; or
  • 4. Subject has a pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40 mmHg or RV systolic pressure (RVSP) as estimated by echo exceeds 40 mmHg), or significant physiologically-impairing lung disease; or
  • 5. Subject has a pre-existing pacing or defibrillation leads; or
  • 6. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
  • 7. Subject has an implanted vena cava filter; or
  • 8. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
  • 9. Subject has an implanted leadless cardiac pacemaker.