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Completed

NCT Number: NCT00182416

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

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.

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Key information

Conditions

Pacemaker Dependence Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

66 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences - General Division, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pacemaker

Device

Primary outcomes

  1. Predictors of future pacemaker dependence

  2. Feasibility of the trial

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Medtronic
  • Sunnybrook Health Sciences Centre

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Oct 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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