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Spontaneous Atrioventricular Conduction Preservation (CAN-SAVER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01015859
First Posted: November 18, 2009
Last Update Posted: October 30, 2013
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.
Collaborator:
Sorin Group Canada
Information provided by (Responsible Party):
Bernard Thibault, Montreal Heart Institute
  Purpose

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.


Condition Intervention Phase
Patients With Pacemaker With Conduction Problems Device: Pacing mode Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)

Further study details as provided by Bernard Thibault, Montreal Heart Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 370
Study Start Date: June 2006
Study Completion Date: October 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: Pacing mode
To determine which mode (DDD vs AAI SafeR)minimizes ventricular pacing

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015859


Locations
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Grey Nuns Hospital, Edmonton
Edmonton, Alberta, Canada, T6L 5X8
Canada, Ontario
Kingston Hospital, Queens University
Kingston, Ontario, Canada, K7L 2V7
Southlake Regional Hospital
Newmarket, Ontario, Canada, L3Y 2P9
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie
Québec, Quebec, Canada, G1V 4G5
Hôtel-Dieu de St Jérome
St Jérome, Quebec, Canada, J7Z 5T3
Centre hospitalier régional de Trois-Rivières
Trois-Rivières, Quebec, Canada, G8Z 3R9
Canada, Saskatchewan
Royal University Hospital, Saskatoon
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Montreal Heart Institute
Sorin Group Canada
Investigators
Principal Investigator: Bernard Thibault, MD Montreal Heart Institute, Research Centre
  More Information

Responsible Party: Bernard Thibault, Cardiologist, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01015859     History of Changes
Other Study ID Numbers: Protocol IGxD04
First Submitted: November 16, 2009
First Posted: November 18, 2009
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Bernard Thibault, Montreal Heart Institute:
AV conduction
Atrial fibrillation