Status:
COMPLETED
Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot Trial
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Medtronic
Sunnybrook Health Sciences Centre
Conditions:
Pacemaker Dependence
Eligibility:
All Genders
66+ years
Phase:
PHASE3
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 adva...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00182416
Start Date
May 1 2004
End Date
January 1 2006
Last Update
October 19 2007
Active Locations (5)
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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