Clinical trial NCT01015859: Spontaneous Atrioventricular Conduction Preservation
Official title: A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients With Pacemaker With Conduction Problems
Keywords: AV conduction
Atrial fibrillation
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Sorin Group Canada
First posted: 2009-11-18
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: to evaluate the effectiveness of SafeR
timeFrame: 1 and 3 years
measure: preserve natural AV conduction compared to DDD Long AVD
timeFrame: 1 and 3 years
measure: demonstrate the effectiveness of SafeR to reduce AF incidence on a LT basis
timeFrame: 1 and 3 years
measure: compare the effects of SafeR vs DDD Long AVD on LV function
timeFrame: 1 and 3 years
Secondary outcomes:
measure: total mortality
timeFrame: 1 and 3 years
measure: CHF-related mortality & hospitalisations
timeFrame: 1 and 3 years
measure: evolution of systemic BP
timeFrame: 1 and 3 years
measure: AF-related AEs
timeFrame: 1 and 3 years
measure: evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments)
timeFrame: 1 and 3 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Hospital, Edmonton
state: Alberta
city: Kingston
country: Canada
facility: Kingston Hospital, Queens University
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Hospital
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie
state: Quebec
city: St Jérome
country: Canada
facility: Hôtel-Dieu de St Jérome
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre hospitalier régional de Trois-Rivières
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital, Saskatoon
state: Saskatchewan
Study officials:
affiliation: Montreal Heart Institute, Research Centre
name: Bernard Thibault, MD
role: PRINCIPAL_INVESTIGATOR
References: