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Sponsors and Collaborators: |
Hamilton Health Sciences Medtronic Sunnybrook Health Sciences Centre |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00182416 |
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.
Condition | Intervention | Phase |
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Pacemaker Dependence |
Device: pacemaker |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot Trial |
Ages Eligible for Study: | 66 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has high risk of being pacemaker dependent by (at least one of the following):
Exclusion Criteria:
Canada, Ontario | |
Hamilton Health Sciences - General Division | |
Hamilton, Ontario, Canada | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 | |
Kingston General Hospital | |
Kingston, Ontario, Canada, K7L 2V7 | |
St. Mary's General Hospital | |
Kitchener, Ontario, Canada, N2M 1B2 | |
University of Ottawa Heart Institute | |
Ottawa, Ontario, Canada, K1Y 4W7 |
Study Chair: | Eugene Crystal, MD | Sunnybrook & Women's College Health Sciences Centre |
Principal Investigator: | Robin S Roberts | McMaster Univeristy, Department of Clinical Epidemiology & Biostatistics |
Principal Investigator: | Stuart Connolly, MD | Hamilton Health Sciences - General Division |
Principal Investigator: | Paul Dorian, MD | St. Michael's Hospital, Toronto |
Study ID Numbers: | CTMG-2005-CTOPPII |
Study First Received: | September 13, 2005 |
Last Updated: | October 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00182416 History of Changes |
Health Authority: | Canada: Health Canada |
pacemakers atrial fibrillation stroke cardiovascular death |
Death Cerebral Infarction Stroke Atrial Fibrillation |