SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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Septal Pacing for Atrial Fibrillation Suppression Evaluation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Pacemaker implantation with RA lead in LAS position
* Device: Pacemaker implantation with RA lead in LAS position
* Device: Pacemaker implantation with RA lead in RAA position
* Device: Pacemaker implantation with RA lead in RAA position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Have a conventional indication for a pacemaker due to either sinus or atrioventricular (AV) node diseases. Provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations. Be at least 18 years old. Exclusion Criteria: Already implanted with a pacemaker or implantable cardioverter defibrillator (ICD). Are expected to have heart surgery within the next 6 months. Have angina pectoris, New York Heart Association (NYHA) Class III or Class IV. Are expected not to be able to tolerate high rate pacing. Have less than 12 months' life expectancy. Are on the cardiac transplantation list. Are in chronic AF. Have a reversible aetiology of AF (e.g., hyperthyroidism, acute post-cardiac surgery AF, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAS + DAO ON<br>The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON. | Device: Pacemaker implantation with RA lead in LAS position<br>* Pacemaker implantation with RA lead placed in low atrial septal position<br>* Other names: Identity ADx DR device;|
| Experimental: LAS + DAO OFF<br>The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF. | Device: Pacemaker implantation with RA lead in LAS position<br>* Pacemaker implantation with RA lead placed in low atrial septal position<br>* Other names: Identity ADx DR pacemaker;|
| Experimental: RAA + DAO ON<br>The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON. | Device: Pacemaker implantation with RA lead in RAA position<br>* Pacemaker implantation with RA lead placed in right atrial appendage position<br>* Other names: Identity ADx DR pacemaker;|
| Active Comparator: RAA + DAO OFF<br>The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF. | Device: Pacemaker implantation with RA lead in RAA position<br>* Pacemaker implantation with RA lead placed in right atrial appendage position<br>* Other names: Identity ADx DR pacemaker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent AF and chronic AF |  | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinus node disease, AV node disease