Dual Chamber Versus Single Chamber Cardiac Pacing in People 80 Years of Age and Older

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pacing the Octogenarian Plus Population (POPP) A Comparison of Physiologic Versus Ventricular Pacing in Those Who Are 80 Years of Age and Older

Conditions
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Atrial Fibrillation, Cardiac Pacing, Artificial

Intervention / Treatment
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* Device: Dual chamber cardiac pacemaker
* Device: Single chamber cardiac pacemaker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle. | Device: Dual chamber cardiac pacemaker<br>* Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle.<br>|
| Other: 2<br>Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle. | Device: Single chamber cardiac pacemaker<br>* Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physiologic pacing, ventricular pacing, hospitalizations