Evaluation of a New Cardiac Pacemaker

An evaluation of a safety and performance of a new cardiac pacemaker

Inclusion Criteria:

• Subject must have one of the following clinical indications:

  1. Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or
  2. 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
  3. Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and

• Subject ≥18 years of age;

• Subject has life expectancy of at least one year;

• Subject is not enrolled in another clinical investigation;

• Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams;

• Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC;

• If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.

Exclusion Criteria:

• Pacemaker dependent;
• Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing;
• Hypersensitivity to < 1 mg of dexamethasone sodium phosphate;
• Mechanical tricuspid valve prosthesis;
• Pre-existing pulmonary arterial (PA) hypertension or significant physiologically-impairing lung disease;
• Pre-existing pacing or defibrillation leads;
• Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT);
• Presence of implanted vena cava filter;
• Presence of implanted leadless cardiac pacemaker;
• Pregnant or breastfeeding.