Pacing the Octogenarian Plus Population (POPP) A Comparison of Physiologic Versus Ventricular Pacing in Those Who Are 80 Years of Age and Older
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Calgary
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 80 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle.
Intervention: Dual chamber cardiac pacemaker (Device)
2
Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle.
Intervention: Single chamber cardiac pacemaker (Device)
Outcomes
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
Time Frame: approximately 3 - 5 years
Secondary Outcomes
- To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life(approximately 3 - 5 years)
Investigators
Dr. Anne M. Gillis
Professor of Medicine, University of Calgary
University of Calgary