The LEADLESS Observational Study
The LEADLESS Observational Study
The objective of the study is to confirm clinical performance and safety of the Nanostim
 leadless cardiac pacemaker system within its intended use and according to its instructions
 for use.
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 2º 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; and

 -  Subject has life expectancy of at least one year and is a suitable candidate based on
 overall health and well-being; and

 -  Subject is not enrolled in another clinical investigation with a treatment arm or that
 could confound the results of this study; 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 written informed consent, approved by the EC; and

 -  Subject is not pregnant and does not plan on getting pregnant during the course of the
 study.

 Exclusion Criteria:

 -  Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial
 blood pressure with the onset of ventricular pacing; or

 -  Hypersensitivity to < 1 mg of dexamethasone sodium phosphate; or

 -  Mechanical tricuspid valve prosthesis; or

 -  Pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40mmHg
 or RV systolic pressure (RVSP) as estimated by echo exceeds 40mmHg) or significant
 physiologically-impairing lung disease (has severe pulmonary disease producing
 frequent hospitalization for respiratory distress or requiring continuous home
 oxygen); or

 -  Pre-existing ventricular pacing or defibrillation leads; or

 -  Current implantation of either conventional or subcutaneous implantable cardioverter
 defibrillator (ICD) or cardiac resynchronization therapy (CRT); or

 -  Presence of implanted vena cava filter; or

 -  Evidence of thrombosis in one of the veins used for access during the procedure; or

 -  Cardiovascular or peripheral vascular surgery/intervention within 30 days of
 enrolment; or

 -  Presence of implanted leadless cardiac pacemaker