Spontaneous Atrioventricular Conduction Preservation (CAN-SAVER)

This study has been completed.
Sponsor:
Collaborator:
Sorin Group Canada
Information provided by (Responsible Party):
Bernard Thibault, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01015859
First received: November 16, 2009
Last updated: October 29, 2013
Last verified: October 2013

November 16, 2009
October 29, 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 ] [ Designated as safety issue: Yes ]
  • preserve natural AV conduction compared to DDD Long AVD [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]
  • demonstrate the effectiveness of SafeR to reduce AF incidence on a LT basis [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]
  • compare the effects of SafeR vs DDD Long AVD on LV function [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01015859 on ClinicalTrials.gov Archive Site
  • total mortality [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]
  • CHF-related mortality & hospitalisations [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]
  • evolution of systemic BP [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]
  • AF-related AEs [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]
  • evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments) [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01015859
Protocol IGxD04
Yes
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