Dual Chamber Versus Single Chamber Cardiac Pacing in People 80 Years of Age and Older - Full Text View

Sponsors and Collaborators:	University of Calgary Calgary Health Trust
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00116987

Purpose

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

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Calgary:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life [ Time Frame: approximately 3 - 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	August 2003
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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 Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle.
2 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 Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle.

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

Ages Eligible for Study:	80 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116987

Contacts

Contact: Cynthia Chen, MSc., M.D.

403-220-2544

jichen@ucalgary.ca

Locations

Canada, Alberta
University of Calgary	Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Cynthia Chen, MSc., M.D. 403-220-2544 jichen@ucalgary.ca

Sponsors and Collaborators

University of Calgary

Calgary Health Trust

Investigators

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

More Information

Responsible Party:	University of Calgary ( Anne M. Gillis M.D. )
Study ID Numbers:	17096
Study First Received:	June 30, 2005
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00116987
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

physiologic pacing
ventricular pacing
hospitalizations

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009