Clinical trial NCT00116987: Dual Chamber Versus Single Chamber Cardiac Pacing in People 80 Years of Age and Older
Official title: Pacing the Octogenarian Plus Population (POPP) A Comparison of Physiologic Versus Ventricular Pacing in Those Who Are 80 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Cardiac Pacing, Artificial
Keywords: physiologic pacing
ventricular pacing
hospitalizations
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Calgary Health Trust
First posted: 2005-07-01
Enrollment: 800
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes
timeFrame: approximately 3 - 5 years
Secondary outcomes:
measure: To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life
timeFrame: approximately 3 - 5 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: Director of Pacing and Electrophysiology, Professor of Medicine, University of Calgary
name: Anne M Gillis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Derek V Exner, MD, MPH
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: D. George Wyse, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: L. Brent Mitchell, MD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Robert S Sheldon, MD, Ph D
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: John M Rothschild, MD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Henry J Duff, MD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: John Burgess, MD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Alexander Bayes, MD
role: STUDY_DIRECTOR
References: