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Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot Trial

NCT00182416 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2007-10-19

No results posted yet for this study

Summary

Pacemaker therapy has been recognized as effective for the control of sinus and atrio-ventricular (AV) node dysfunction. Single chamber pacing when compared with dual chamber pacing, has numerous advantages of low complication rates, lower cost, better longevity, with non-inferiority in the quality of life and hard outcomes proven in direct randomized comparisons. However, comparison between single and dual chamber pacers was never adequate, since not more then half of the patients in the trials were actually using pacemakers for the majority of the time. Routine dual chamber pacing using a right ventricle apical lead is also associated with significant increase in peri-operative and remote complications. Some of these complications may be related to ventricular desynchronization secondary to the pacing location, which is potentially avoidable by using biventricular pacing. A randomized trial which will compare single chamber rate responsive pacing to the best available modification of dual chamber pacing (biventricular pacing) in suitable patients is therefore warranted.

Conditions

  • Pacemaker Dependence

Interventions

DEVICE

pacemaker

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Eugene Crystal, MD · Sunnybrook & Women's College Health Sciences Centre

  • Robin S Roberts · McMaster Univeristy, Department of Clinical Epidemiology & Biostatistics

  • Stuart Connolly, MD · Hamilton Health Sciences - General Division

  • Paul Dorian, MD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Completion
2006-01-31

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT00182416 on ClinicalTrials.gov