Evaluation of a New Cardiac Pacemaker
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.