Spontaneous Atrioventricular Conduction Preservation

Phase 4

Completed

• Conditions: Patients With Pacemaker With Conduction Problems

• Registration Number: NCT01015859
• Lead Sponsor: Montreal Heart Institute

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 available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Primary Completion: 2012-08
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Grey Nuns Hospital, Edmonton; 🇨🇦 Edmonton, Alberta, Canada

Kingston Hospital, Queens University; 🇨🇦 Kingston, Ontario, Canada

Southlake Regional Hospital; 🇨🇦 Newmarket, Ontario, Canada

St Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Institut Universitaire de Cardiologie et de Pneumologie; 🇨🇦 Québec, Quebec, Canada

Hôtel-Dieu de St Jérome; 🇨🇦 St Jérome, Quebec, Canada

Centre hospitalier régional de Trois-Rivières; 🇨🇦 Trois-Rivières, Quebec, Canada

Royal University Hospital, Saskatoon; 🇨🇦 Saskatoon, Saskatchewan, Canada