Evaluation of a New Cardiac Pacemaker

Fecha de inicio: 1 de diciembre de 2012

Inclusion Criteria: Subject must have one of the following clinical indications: Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; 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 ≥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.