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

This study has been completed.
Sponsor:
Collaborators:
Medtronic
Sunnybrook Health Sciences Centre
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182416
First received: September 13, 2005
Last updated: October 18, 2007
Last verified: October 2007
  Purpose

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
Pacemaker Dependence
Device: pacemaker
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Predictors of future pacemaker dependence
  • Feasibility of the trial

Estimated Enrollment: 300
Study Start Date: May 2004
Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has symptomatic bradycardia and is a candidate for first pacemaker implantation
  • Patient has high risk of being pacemaker dependent by (at least one of the following):

    1. Average heart rate of 60 or less on pre-implant Holter
    2. Maximal heart rate of 60 in patient on telemetry monitoring 12 hrs preoperatively, when not under medications decreasing heart rate, or under chronic medical treatment inducing bradycardia, which is unlikely to be changed
    3. First degree AV block with PR intervals > 300 ms, or second degree AV block at heart rates <= 80 bpm.
    4. Dependence for 12 hrs when on temporary pacemaker set at 50 bpm if bradycardia is not secondary to medication, or under chronic medical treatment inducing bradycardia, which is unlikely to be changed.

Exclusion Criteria:

  • Age <= 65 years
  • Chronic Atrial Fibrillation
  • Indication for ICD
  • Non-cardiovascular death is likely to occur within 3 years
  • Geographical, social, or psychiatric reasons making follow-up problematic
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182416

Locations
Canada, Ontario
Hamilton Health Sciences - General Division
Hamilton, Ontario, Canada
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
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Medtronic
Sunnybrook Health Sciences Centre
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00182416     History of Changes
Other Study ID Numbers: CTMG-2005-CTOPPII
Study First Received: September 13, 2005
Last Updated: October 18, 2007
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
pacemakers
atrial fibrillation
stroke
cardiovascular death

ClinicalTrials.gov processed this record on July 10, 2014