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

University of Calgary

Status: Terminated

Conditions: Atrial Fibrillation; Cardiac Pacing, Artificial

Treatments: Device: Dual chamber cardiac pacemaker; Device: Single chamber cardiac pacemaker

Study type: Interventional

Funder types: Other

Identifiers

NCT00116987

17096

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

1

Other group

Description:

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

Treatment:

Device: Dual chamber cardiac pacemaker

2

Other group

Description:

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

Treatment:

Device: Single chamber cardiac pacemaker