Spontaneous Atrioventricular Conduction Preservation (CAN-SAVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01015859
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : October 30, 2013
Sorin Group Canada
Information provided by (Responsible Party):
Bernard Thibault, Montreal Heart Institute

November 16, 2009
November 18, 2009
October 30, 2013
June 2006
August 2012   (Final data collection date for primary outcome measure)
  • to evaluate the effectiveness of SafeR [ Time Frame: 1 and 3 years ]
  • preserve natural AV conduction compared to DDD Long AVD [ 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 ]
Same as current
Complete list of historical versions of study NCT01015859 on Archive Site
  • total mortality [ Time Frame: 1 and 3 years ]
  • CHF-related mortality & hospitalisations [ Time Frame: 1 and 3 years ]
  • evolution of systemic BP [ Time Frame: 1 and 3 years ]
  • AF-related AEs [ Time Frame: 1 and 3 years ]
  • evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments) [ Time Frame: 1 and 3 years ]
Same as current
Not Provided
Not Provided
Spontaneous Atrioventricular Conduction Preservation
A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)

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.

Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Patients With Pacemaker With Conduction Problems
Device: Pacing mode
To determine which mode (DDD vs AAI SafeR)minimizes ventricular pacing
  • No Intervention: DDD long AV delay
    Pacemaker is programmed in DDD mode with long AV delay (250 msec)
  • Active Comparator: AAI SafeR
    Pacemaker is programmed in AAI SafeR mode
    Intervention: Device: Pacing mode
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2013
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Protocol IGxD04
Not Provided
Not Provided
Bernard Thibault, Montreal Heart Institute
Montreal Heart Institute
Sorin Group Canada
Principal Investigator: Bernard Thibault, MD Montreal Heart Institute, Research Centre
Montreal Heart Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP