A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 370
- Locations
- 18
- Primary Endpoint
- to evaluate the effectiveness of SafeR
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
to evaluate the effectiveness of SafeR
Time Frame: 1 and 3 years
demonstrate the effectiveness of SafeR to reduce AF incidence on a LT basis
Time Frame: 1 and 3 years
compare the effects of SafeR vs DDD Long AVD on LV function
Time Frame: 1 and 3 years
preserve natural AV conduction compared to DDD Long AVD
Time Frame: 1 and 3 years
Secondary Outcomes
- evolution of systemic BP(1 and 3 years)
- AF-related AEs(1 and 3 years)
- total mortality(1 and 3 years)
- CHF-related mortality & hospitalisations(1 and 3 years)
- evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments)(1 and 3 years)
Investigators
Bernard Thibault
Cardiologist
Montreal Heart Institute