Ensayos clínicos

Inclusion Criteria:

• 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
  • Subject is ≥ 18 years of age; and
  • Subject has a life expectancy of at least one year; and
  • *Subject is not enrolled in another clinical investigation; and
  • Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
  • 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
  • Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion Criteria:

• Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
• Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP);
• Subject has a mechanical tricuspid valve prosthesis; or
• Subject has a pre-existing endocardial pacing or defibrillation leads; or
• Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
• Subject has an implanted vena cava filter; or
• Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
• *Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
• Subject has an implanted leadless cardiac pacemaker; or 
• *Recent cardiovascular or peripheral vascular surgery within 30 days of enrollment is defined as the following:
  • Percutaneous valvular correction ≤ 30 days;
  • Femoral or abdominal vascular procedure involving incisional access ≤ 30 days;
  • Peripheral arterial endovascular procedure or surgery ≤ 30 days;Cardiac surgery ≤ 72 hrs with ongoing complications, ongoing mediastinal drainage, or re-do sternotomy attributed to bleeding ≤ 30 days;
  • Tricuspid valve replacement or annuloplasty ≤ 30 days;
  • Any endovascular procedure with specified complication ≤ 30 days;
  • Femoral access site-vascular complication including hematoma requiring transfusion, surgical intervention or prolongation of hospitalization, arterio-venous fistula, pseudoaneurysm or tear;
  • New pericardial effusion more than trivial/mild, or requiring percutaneous/surgical drainage.
  • Acute deep venous thrombosis.

Eligibility last updated 8/19/21. Questions regarding updates should be directed to the study team contact.