SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Pacemaker implantation with RA lead in LAS position; Device: Pacemaker implantation with RA lead in RAA position

• Registration Number: NCT00419640
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-09
• Primary Completion: 2012-02
• Study Completion: 2012-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAS + DAO OFF	Pacemaker implantation with RA lead in LAS position	The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF.
RAA + DAO ON	Pacemaker implantation with RA lead in RAA position	The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON.
LAS + DAO ON	Pacemaker implantation with RA lead in LAS position	The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON.
RAA + DAO OFF	Pacemaker implantation with RA lead in RAA position	The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF.

Primary Outcome Measures

Name	Time	Method
Persistent AF and chronic AF	2 years

Secondary Outcome Measures

Name	Time	Method
Safety and efficacy of low septal pacing	2 years
Major cardiovascular events: heart failure, stroke, hospitalization, and cardiovascular mortality	2 years
Quality-of-life questionnaire: Short Form-36 (SF-36)	2 years
Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden	2 years
Number of cardioversions	2 years
Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo	2 years

Trial Locations

Locations (1)

Queen Mary Hospital, The University Hospital of Hong Kong; 🇭🇰 Hong Kong, Hong Kong