Clinical Trials Directory

Trials / Terminated

TerminatedNCT00116987

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

Pacing the Octogenarian Plus Population (POPP) A Comparison of Physiologic Versus Ventricular Pacing in Those Who Are 80 Years of Age and Older

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
800 (estimated)
Sponsor
University of Calgary · Academic / Other
Sex
All
Age
80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEDual chamber cardiac pacemakerPhysiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle.
DEVICESingle chamber cardiac pacemakerVentricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle.

Timeline

Start date
2003-08-01
Primary completion
2008-09-01
Completion
2009-11-01
First posted
2005-07-01
Last updated
2015-06-15

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00116987. Inclusion in this directory is not an endorsement.