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

This study has been terminated.
(Unable to recruit adequate number of participants in required time frame.)
Sponsor:
Collaborator:
Calgary Health Trust
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00116987
First received: June 30, 2005
Last updated: June 1, 2010
Last verified: June 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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: June 2010
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.
Other Name: Dual chamber cardiac pacemaker
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.
Other Name: Single chamber cardiac pacemaker

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
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

No publications provided

Responsible Party: Anne M. Gillis M.D., University of Calgary
ClinicalTrials.gov Identifier: NCT00116987     History of Changes
Other Study ID Numbers: 17096
Study First Received: June 30, 2005
Last Updated: June 1, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
physiologic pacing
ventricular pacing
hospitalizations

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014