Clinical trial NCT00182416: Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot Trial
Official title: Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pacemaker Dependence
Keywords: pacemakers
atrial fibrillation
stroke
cardiovascular death
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Sunnybrook Health Sciences Centre
First posted: 2005-09-16
Enrollment: 300
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Predictors of future pacemaker dependence
measure: Feasibility of the trial
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - General Division
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: St. Mary's General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook & Women's College Health Sciences Centre
name: Eugene Crystal, MD
role: STUDY_CHAIR
affiliation: McMaster Univeristy, Department of Clinical Epidemiology & Biostatistics
name: Robin S Roberts
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences - General Division
name: Stuart Connolly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Paul Dorian, MD
role: PRINCIPAL_INVESTIGATOR
References: