SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

Abbott

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Pacemaker implantation with RA lead in RAA position; Device: Pacemaker implantation with RA lead in LAS position

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419640

CR04032AF

Details and patient eligibility

About

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.

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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385 participants in 4 patient groups

LAS + DAO ON

Experimental group

Description:

The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON.

Treatment:

Device: Pacemaker implantation with RA lead in LAS position

Device: Pacemaker implantation with RA lead in LAS position

LAS + DAO OFF

Experimental group

Description:

The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF.

Treatment:

Device: Pacemaker implantation with RA lead in LAS position

Device: Pacemaker implantation with RA lead in LAS position

RAA + DAO ON

Experimental group

Description:

The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON.

Treatment:

Device: Pacemaker implantation with RA lead in RAA position

Device: Pacemaker implantation with RA lead in RAA position

RAA + DAO OFF

Active Comparator group

Description:

The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF.

Treatment:

Device: Pacemaker implantation with RA lead in RAA position

Device: Pacemaker implantation with RA lead in RAA position