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

NCT00182416 | Completed Phase 3

• 1 other identifier: CTMG-2005-CTOPPII
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Pacemaker Dependence

Keywords

pacemakers; atrial fibrillation; stroke; cardiovascular death

Outcome Measures

Primary Outcomes (2)

• Predictors of future pacemaker dependence

• Feasibility of the trial

Interventions

pacemaker DEVICE

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Medtronic: collaborator
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (5)

Hamilton Health Sciences - General Division

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

St. Mary's General Hospital

Kitchener, Ontario, N2M 1B2, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Eugene Crystal, MD

  Sunnybrook & Women's College Health Sciences Centre

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2004
• Study Completion: January 1, 2006
• Last Updated: October 19, 2007

Record last verified: 2007-10

Locations

CA (5)