Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

Study Overview
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Brief Summary
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The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients. The expected benefits will be a result of the reduction of the percentage of ventricular pacing. It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation. The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)

Official Title
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Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

Conditions
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Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.

Intervention / Treatment
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* Device: Symphony DR 2550 and REPLY DR cardiac pacemakers
* Device: Symphony DR 2550 and REPLY DR cardiac pacemakers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient primo-implanted with a Symphony 2550 or Reply DR for less than 1 month according to the official guidelines. Patient implanted for sinus node dysfunction (including bradycardia-tachycardia syndrome) or 2nd, advanced or 3rd degree intermittent or allegedly permanent AV block. Patient implanted with a bipolar right atrial lead and a right ventricular lead Patient has signed a consent form after having received the appropriate information Exclusion Criteria: Patient with permanent AF Patient suffering from sustained ventricular arrhythmias Patient with congenital complete heart block Patient with vasovagal syncope, carotid sinus syndrome Patient with AV node ablation Patient having suffered from a myocardial infarction within the last month Patient suffering from severe aortic stenosis Patient suffering from unstable angina pectoris Patient is not able to understand the study objectives and protocol or refuses to co-operate Patient is not available for scheduled follow-up Patient has a life expectancy less than one year Patient is included into another clinical study Patient is minor, this is < 18 years Patient is a pregnant woman Any patient with a contra-indication for the device labeling
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: 1<br>AAIsafeR /SafeR Patient randomized with the SafeR switched ON | Device: Symphony DR 2550 and REPLY DR cardiac pacemakers<br>* AAISafeR/SafeR ON<br>|
| Experimental: 2<br>DDD(R) mode. Patients randomized with the SafeR mode switched OFF | Device: Symphony DR 2550 and REPLY DR cardiac pacemakers<br>* DDD(R) (SafeR OFF)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of paroxysmal AV blocks |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimized ventricular pacing, clinical outcome, SafeR, AAIsafeR, dual chamber pacemaker therapy, % of ventricular pacing, hospitalizations, symptomatic AF