Spontaneous Atrioventricular Conduction Preservation (CAN-SAVER)

University of Montreal

Status and phase

Completed

Phase 4

Conditions

Patients With Pacemaker With Conduction Problems

Treatments

Device: Pacing mode

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01015859

Protocol IGxD04

Details and patient eligibility

About

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.

Enrollment

370 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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