Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.

Detailed Description
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The incidence of Atrial Fibrillation (AF) in Sick Sinus Syndrome patients treated with pacing is quite high. As AF can cause dizziness, fatigue, thromboembolism and ischemic stroke it is clinically relevant. Due to earlier publications pacing modes and lead placement seem to influence the incidence of AF. In this study the incidence of AF will be compared between 4 different atrial lead positions: Free atrial wall right atrial appendage coronary sinus-os Dual site right atrial pacing: b) plus c). The following primary parameters will be evaluated during the study period of 2 years after implantation: Amounts of AF episodes with a duration of > 48 hours Amounts of AF episodes with a duration of > 30 minutes Consultations of physicians due to AF Secondarily, AF burden, Incidence of AF in total, Quality of Life, implant duration and complications will be evaluated.

Official Title
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A Randomized, Prospective Multicenter Study to Examine the Optimal Position of the Atrial Leads for Therapy of the Sinus Node Syndrome

Conditions
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Sick Sinus Syndrome

Intervention / Treatment
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* Device: Pacing leads to be implanted according randomization.
* Device: Selection 9000 prevent AF an Diagnose AF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sick Sinus Syndrome Symptomatic sinus bradycardia Symptomatic SA block Bradycardia-Tachycardia-Syndrom Binodal diseases, Sinus Node Syndrome and high degree AV-Block In case of antiarrhythmic drug therapy: patient must be on a stable dose for at least 3 months before enrollment Exclusion Criteria: Permanent atrial tachycardia that cannot be transferred into sinus rhythm by drugs or electric cardioversion Decompensated heart failure Dilatative cardiomyopathy with an ejection fraction < 35% Hypertrophic obstructive cardiomyopathy Symptomatic hypo- or hyperthyreosis Myocardial infarction less than 6 months ago Planned cardiac surgery intervention Pregnant woman Patients under 18 years of age Patients involved in other studies Patients, already implanted with other (cardiac) leads Patients with reduced expectancy of life due to other diseases Patients who are not able to agree in participation of the study Patients, who cannot attend follow-up visits due to their place of residence

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pacing leads to be implanted according randomization.|nan|
|Device: Selection 9000 prevent AF an Diagnose AF|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of AF is determined via memory of the pacemaker, which is saved at every follow-up visit at 1 and 10 days after implant and further on at 3, 6, 12, 18 and 24 months after implant. |  |  | 
| 24-Hour ECG and treadmill exercise as well as echocardiography shall be performed before implant and 6, 12 and 24 months after implant |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treadmill exercise test as well as echocardiography shall be performed before implant and 6, 12 and 24 month after implant. |  |  | 
| Quality of Life questionnaires are obtained before implant and 12 and 24 months after implants |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Pacing, artificial, Atrial fibrillation, Pacemaker leads, Lead positions