Spontaneous Atrioventricular Conduction Preservation (CAN-SAVER)

October 29, 2013 updated by: Bernard Thibault, Montreal Heart Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

370

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada, T6L 5X8
        • Grey Nuns Hospital, Edmonton
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Hospital, Queens University
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie
      • St Jérome, Quebec, Canada, J7Z 5T3
        • Hôtel-Dieu de St Jérome
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Centre Hospitalier Regional de Trois-Rivieres
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital, Saskatoon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to evaluate the effectiveness of SafeR
Time Frame: 1 and 3 years
1 and 3 years
preserve natural AV conduction compared to DDD Long AVD
Time Frame: 1 and 3 years
1 and 3 years
demonstrate the effectiveness of SafeR to reduce AF incidence on a LT basis
Time Frame: 1 and 3 years
1 and 3 years
compare the effects of SafeR vs DDD Long AVD on LV function
Time Frame: 1 and 3 years
1 and 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
total mortality
Time Frame: 1 and 3 years
1 and 3 years
CHF-related mortality & hospitalisations
Time Frame: 1 and 3 years
1 and 3 years
evolution of systemic BP
Time Frame: 1 and 3 years
1 and 3 years
AF-related AEs
Time Frame: 1 and 3 years
1 and 3 years
evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments)
Time Frame: 1 and 3 years
1 and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Collaborators

Sorin Group Canada

Investigators

  • Principal Investigator: Bernard Thibault, MD, Montreal Heart Institute, Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (ESTIMATE)

November 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Protocol IGxD04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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