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Spontaneous Atrioventricular Conduction Preservation (CAN-SAVER)

This study is ongoing, but not recruiting participants.
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: May 6, 2012
Last verified: May 2012
History of Changes
  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 Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 370
Study Start Date: June 2006
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015859

Locations
Canada, Alberta
Grey Nuns Hospital, Edmonton
Edmonton, Alberta, Canada, T6L 5X8
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
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

No publications provided

Responsible Party: Bernard Thibault, Cardiologist, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01015859     History of Changes
Other Study ID Numbers: Protocol IGxD04
Study First Received: November 16, 2009
Last Updated: May 6, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Montreal Heart Institute:
AV conduction
Atrial fibrillation

ClinicalTrials.gov processed this record on May 16, 2013