SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

Septal Pacing for Atrial Fibrillation Suppression Evaluation

This is a randomized, parallel, single-blinded multi-center study. The objective is to compare the long term clinical outcomes among the site of atrial pacing and to compare the long term effect of the atrial fibrillation (AF) Suppression algorithm.

Inclusion Criteria:

1. Have a history of paroxysmal AF with documented AF episode within the last 6 months; documentation of AF is required. It can be documented by one of the following:

   • Holter documentation and the strip must be at least 30 seconds; OR
   • one page of 12-lead electrocardiogram (ECG); OR
   • transtelephonic recording for more than 15 seconds.

2. Have a conventional indication for a pacemaker due to either sinus or atrioventricular (AV) node diseases.

3. Provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

4. Be at least 18 years old.

Exclusion Criteria:

1. Already implanted with a pacemaker or implantable cardioverter defibrillator (ICD).
2. Are expected to have heart surgery within the next 6 months.
3. Have angina pectoris, New York Heart Association (NYHA) Class III or Class IV.
4. Are expected not to be able to tolerate high rate pacing.
5. Have less than 12 months' life expectancy.
6. Are on the cardiac transplantation list.
7. Are in chronic AF.
8. Have a reversible aetiology of AF (e.g., hyperthyroidism, acute post-cardiac surgery AF, etc.).