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Unable to recruit adequate number of participants in required time frame.
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| Name | Class |
|---|---|
| Calgary Health Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle. |
|
| 2 | Other | Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual chamber cardiac pacemaker | Device | Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes | approximately 3 - 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life | approximately 3 - 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne M Gillis, MD | Director of Pacing and Electrophysiology, Professor of Medicine, University of Calgary | Principal Investigator |
| Derek V Exner, MD, MPH | University of Calgary | Study Director |
| D. George Wyse, MD, PhD | University of Calgary | Study Director |
| L. Brent Mitchell, MD | University of Calgary | Study Director |
| Robert S Sheldon, MD, Ph D | University of Calgary | Study Director |
| John M Rothschild, MD | University of Calgary | Study Director |
| Henry J Duff, MD | University of Calgary | Study Director |
| John Burgess, MD | University of Calgary | Study Director |
| Alexander Bayes, MD | University of Calgary | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Single chamber cardiac pacemaker | Device | Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |