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

NCT ID: NCT00116987

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2009-11-30

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.

Conditions

Atrial Fibrillation; Cardiac Pacing, Artificial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle.

Group Type: OTHER

Dual chamber cardiac pacemaker

Intervention Type: DEVICE

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.

Group Type: OTHER

Single chamber cardiac pacemaker

Intervention Type: DEVICE

Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Calgary Health Trust

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anne M. Gillis

Professor of Medicine, University of Calgary

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne M Gillis, MD

Role: PRINCIPAL_INVESTIGATOR

Director of Pacing and Electrophysiology, Professor of Medicine, University of Calgary

Derek V Exner, MD, MPH

Role: STUDY_DIRECTOR

University of Calgary

D. George Wyse, MD, PhD

Role: STUDY_DIRECTOR

University of Calgary

L. Brent Mitchell, MD

Role: STUDY_DIRECTOR

University of Calgary

Robert S Sheldon, MD, Ph D

Role: STUDY_DIRECTOR

University of Calgary

John M Rothschild, MD

Role: STUDY_DIRECTOR

University of Calgary

Henry J Duff, MD

Role: STUDY_DIRECTOR

University of Calgary

John Burgess, MD

Role: STUDY_DIRECTOR

University of Calgary

Alexander Bayes, MD

Role: STUDY_DIRECTOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

17096

Identifier Type: -

Identifier Source: org_study_id