Of the 19,000 pacemakers implanted across Canada in 2002, 1/3 of them were for patients 80 years and older. This is the fastest growing segment of our population, yet no study has specifically been done in this age group to determine the optimal pacing mode. We wish to determine whether dual chamber or single chamber pacing is associated with a reduction in emergency room visits or hospitalizations for cardiovascular causes (e.g., congestive heart failure (CHF), atrial fibrillation (AF)) resulting in improved quality of life.

Condition	Intervention
Atrial Fibrillation Cardiac Pacing, Artificial	Device: Dual chamber cardiac pacemaker  Device: Single chamber cardiac pacemaker

Further Study Details: 

Primary Outcomes: To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes
Secondary Outcomes: To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life
Expected Total Enrollment:  800

Many patients who are 80 years of age and older, develop AF or CHF. Physiologic pacing has been shown to prevent AF compared to ventricular pacing. Whether prevention of AF and CHF by physiologic pacing reduces emergency room visits or hospitalizations for cardiovascular causes in this population in unknown.

The investigators wish to determine the optimal pacing mode for this patient population that would enable optimal management of cardiovascular problems, resulting in improved quality of life and minimizing use of health care facilities.

Patients recruited to the study will be randomized to either DDDR or VVIR pacing, and followed in the clinic every 6 months for the 3 years of the study.

Ages Eligible for Study:  80 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 80 years of age and older
• Symptomatic bradycardia

Exclusion Criteria:

• Permanent atrial fibrillation
• Previous pacemaker implant
• Life expectancy less than 1 year
• Geographic isolation
• Unable to give informed consent

Please refer to this study by ClinicalTrials.gov identifier  NCT00116987

Margaret L Morck, B.A., RN      403-220-2544    mmorck@ucalgary.ca

Canada, Alberta
      University of Calgary, Calgary,  Alberta,  T2N 4N1,  Canada; Recruiting

Study chairs or principal investigators

Anne M Gillis,  Principal Investigator,  Director of Pacing and Electrophysiology, Professor of Medicine, University of Calgary   

Study ID Numbers:  17096
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 30, 2005
ClinicalTrials.gov Identifier:  NCT00116987
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-07-05