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

Tracking Information

First Received Date ^ICMJE

November 16, 2009

Last Updated Date

May 6, 2012

Start Date ^ICMJE

June 2006

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01015859 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Spontaneous Atrioventricular Conduction Preservation

Official Title ^ICMJE

A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Patients With Pacemaker With Conduction Problems

Intervention ^ICMJE

Device: Pacing mode

To determine which mode (DDD vs AAI SafeR)minimizes ventricular pacing

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

370

Estimated Completion Date

September 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01015859

Other Study ID Numbers ^ICMJE

Protocol IGxD04

Has Data Monitoring Committee

Yes

Responsible Party

Bernard Thibault, Montreal Heart Institute

Study Sponsor ^ICMJE

Montreal Heart Institute

Collaborators ^ICMJE

Sorin Group Canada

Investigators ^ICMJE

Principal Investigator:

Bernard Thibault, MD

Montreal Heart Institute, Research Centre

Information Provided By

Montreal Heart Institute

Verification Date

May 2012

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

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