Patients With Pacemaker With Conduction Problems
Conditions
Keywords
AV conduction, Atrial fibrillation
Brief summary
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.
Interventions
DEVICEPacing mode
To determine which mode (DDD vs AAI SafeR)minimizes ventricular pacing
Sponsors
Sorin Group Canada
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| CHF-related mortality & hospitalisations | 1 and 3 years |
| evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments) | 1 and 3 years |
| evolution of systemic BP | 1 and 3 years |
| total mortality | 1 and 3 years |
| AF-related AEs | 1 and 3 years |
Countries
Canada
Outcome results
None listed