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Spontaneous Atrioventricular Conduction Preservation

NCT01015859 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2013-10-30

No results posted yet for this study

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.

Conditions

  • Patients With Pacemaker With Conduction Problems

Interventions

DEVICE

Pacing mode

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

Sponsors & Collaborators

  • Sorin Group Canada

    collaborator INDUSTRY

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Bernard Thibault, MD · Montreal Heart Institute, Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2012-08-31
Completion
2013-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015859 on ClinicalTrials.gov