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

Pacemaker Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182416
• Other study ID #: CTMG-2005-CTOPPII
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 18, 2007
• Start date: May 2004
• Est. completion date: January 2006

Study information

• Verified date: October 2007
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 66 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pacemaker Dependence

Intervention

Device:
• pacemaker

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences - General Division	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	St. Mary's General Hospital	Kitchener	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Medtronic, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictors of future pacemaker dependence
Primary	Feasibility of the trial