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

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT00182416

Collaborator

Medtronic (Industry), Sunnybrook Health Sciences Centre (Other)

300

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker Dependence	Device: pacemaker	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2004

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Predictors of future pacemaker dependence []
Feasibility of the trial []

Eligibility Criteria

Criteria

Ages Eligible for Study:

66 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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):

Average heart rate of 60 or less on pre-implant Holter
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
First degree AV block with PR intervals > 300 ms, or second degree AV block at heart rates <= 80 bpm.
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

Locations

	Site	City	State	Country	Postal Code
1	Hamilton Health Sciences - General Division	Hamilton	Ontario	Canada
2	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
3	St. Mary's General Hospital	Kitchener	Ontario	Canada	N2M 1B2
4	University of Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
5	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, Unity Health Toronto