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

Not Applicable

Terminated

• Conditions: Cardiac Pacing, Artificial; Atrial Fibrillation
• Interventions: Device: Single chamber cardiac pacemaker; Device: Dual chamber cardiac pacemaker

• Registration Number: NCT00116987
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-01
• Primary Completion: 2008-09
• Study Completion: 2009-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-11
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• 80 years of age and older
• Symptomatic bradycardia

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Exclusion Criteria

• Permanent atrial fibrillation
• Previous pacemaker implant
• Life expectancy less than 1 year
• Geographic isolation
• Unable to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	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.
1	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.

Primary Outcome Measures

Name	Time	Method
To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes	approximately 3 - 5 years

Secondary Outcome Measures

Name	Time	Method
To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life	approximately 3 - 5 years

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada