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Spontaneous Atrioventricular Conduction Preservation

NCT ID: NCT01015859

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Patients With Pacemaker With Conduction Problems

Keywords

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AV conduction Atrial fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DDD long AV delay

Pacemaker is programmed in DDD mode with long AV delay (250 msec)

Group Type NO_INTERVENTION

No interventions assigned to this group

AAI SafeR

Pacemaker is programmed in AAI SafeR mode

Group Type ACTIVE_COMPARATOR

Pacing mode

Intervention Type DEVICE

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

Interventions

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Pacing mode

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorin Group Canada

INDUSTRY

Sponsor Role collaborator

Montreal Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Bernard Thibault

Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernard Thibault, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute, Research Centre

Locations

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Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

Grey Nuns Hospital, Edmonton

Edmonton, Alberta, Canada

Site Status

Kingston Hospital, Queens University

Kingston, Ontario, Canada

Site Status

Southlake Regional Hospital

Newmarket, Ontario, Canada

Site Status

St Michael's Hospital

Toronto, Ontario, Canada

Site Status

Institut Universitaire de Cardiologie et de Pneumologie

Québec, Quebec, Canada

Site Status

Hôtel-Dieu de St Jérome

Saint Jérome, Quebec, Canada

Site Status

Centre hospitalier régional de Trois-Rivières

Trois-Rivières, Quebec, Canada

Site Status

Royal University Hospital, Saskatoon

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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Protocol IGxD04

Identifier Type: -

Identifier Source: org_study_id