Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Studies have indicated that an increased amount of stimulation from the pacemaker in the atria is associated with an increased amount of AF. The aim of the present study is to test the hypothesis that a reduction of stimulation from the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.

Official Title
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A Randomised Controlled Trial of Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome and Dual Chamber Pacemaker.

Conditions
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Sinus Node Disease, Atrial Fibrillation

Intervention / Treatment
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* Device: DDDR-60
* Device: DDD-40


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sick sinus syndrome with and without AV block and indication for first-time implantation of a DDD pacemaker: symptomatic sinus pauses (>2 sec) or bradycardia with or without paroxysmal AF. Age ≥18 years. Patient informed consent. Exclusion Criteria: Permanent or persisting (>7 days) AF prior to implantation. Persisting symptomatic sinus bradycardia and/or chronotropic incompetence where DDD-pacing at a frequency of >40 bpm is indicated (verified with long term ECG monitoring). Life expectancy <2 years. Participation in another interventional research study. Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT). Pregnancy.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: DDDR-60<br>DDDR, lower pacing rate 60 bpm, RR activated (low-moderate) | Device: DDDR-60<br>* DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)<br>|
| Experimental: DDD-40<br>DDD, lower pacing rate 40 bpm, RR function off | Device: DDD-40<br>* DDD, lower pacing rate 40 bpm, RR function off<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first episode of AF>6 min detected by the pacemaker | First episode of AF > 6 min detected by the device | Within two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first episode of AF>6 hours detected by the pacemaker | First episode of AF > 6 hours detected by the device | Within two years | 
| Time to first episode of AF>24 hours detected by the pacemaker | First episode of AF > 24 hours detected by the device | Within two years | 
| Time to direct current (DC) cardioversion or medical cardioversion for AF | Time to direct current (DC) cardioversion or medical cardioversion for AF | Within two years | 
| Time to stroke, transient ischemic attack (TIA), or thromboembolic event | Time to stroke, transient ischemic attack (TIA), or thromboembolic event | Within two years | 
| Time to death | Time to all cause death | Within two years | 
| QOL | Quality of life assessment with SF-36 | After 12 months | 
| 6MHWT | 6-minute hall walk test | After 12 months | 
| Time to need for reprogramming of the pacing rate (cross-over) | Time to need for reprogramming of the pacing rate (cross-over) | Within 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinus node disease, Atrial fibrillation, Pacing