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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00116987
• Other study ID #: 17096
• Status: Terminated
• Phase: N/A
• First received: June 30, 2005
• Last updated: June 11, 2015
• Start date: August 2003
• Est. completion date: November 2009

Study information

• Verified date: June 2015
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 800
• Est. completion date: November 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Pacing, Artificial

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Calgary Health Trust

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life		approximately 3 - 5 years	Yes