Spontaneous Atrioventricular Conduction Preservation

Study Overview
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Brief Summary
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The aims of this study are to assess the clinical benefits resulting from SafeR by comparison with standard dual chamber programming (DDD) with a long atrioventricular (AV) delay. The benefits will be assessed by comparing the percentage of ventricular pacing, the incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed through echo parameter and atrial natriuretic peptide/brain natriuretic peptide (ANP/BNP) measurements.

Official Title
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A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)

Conditions
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Patients With Pacemaker With Conduction Problems

Intervention / Treatment
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* Device: Pacing mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation3) may be included in the study. Exclusion Criteria: The patients presenting with one or more of the following characteristics cannot be included: Permanent complete AV block Permanent atrial and/or ventricular arrhythmias already implanted with a cardioverter-defibrillator (ICD) Likely to have a cardiac surgery in the next six months, mainly for: severe coronary artery disease severe valvular disease AV node ablation Refuses to sign an consent form after having received the appropriate information Refuses to co-operate Not able to understand the study objectives and protocol Not available for scheduled follow-up With a life expectancy less than one year Already included into another clinical study competing with the objectives of the CAN-SAVE R study <18 years old

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 |
| --- | --- |
| No Intervention: DDD long AV delay<br>Pacemaker is programmed in DDD mode with long AV delay (250 msec) | |
| Active Comparator: AAI SafeR<br>Pacemaker is programmed in AAI SafeR mode | Device: Pacing mode<br>* To determine which mode (DDD vs AAI SafeR)minimizes ventricular pacing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the effectiveness of SafeR |  | 1 and 3 years | 
| preserve natural AV conduction compared to DDD Long AVD |  | 1 and 3 years | 
| demonstrate the effectiveness of SafeR to reduce AF incidence on a LT basis |  | 1 and 3 years | 
| compare the effects of SafeR vs DDD Long AVD on LV function |  | 1 and 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total mortality |  | 1 and 3 years | 
| CHF-related mortality & hospitalisations |  | 1 and 3 years | 
| evolution of systemic BP |  | 1 and 3 years | 
| AF-related AEs |  | 1 and 3 years | 
| evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments) |  | 1 and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AV conduction, Atrial fibrillation