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

Primary Purpose

Atrial Fibrillation, Cardiac Pacing, Artificial

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Dual chamber cardiac pacemaker

Single chamber cardiac pacemaker

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring physiologic pacing, ventricular pacing, hospitalizations

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes

Secondary Outcome Measures

To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life

Full Information

NCT ID

NCT00116987

First Posted

June 30, 2005

Last Updated

June 11, 2015

Sponsor

University of Calgary

Collaborators

Calgary Health Trust

1. Study Identification

Unique Protocol Identification Number

NCT00116987

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

Unable to recruit adequate number of participants in required time frame.

Study Start Date

August 2003 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

Collaborators

Calgary Health Trust

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Cardiac Pacing, Artificial

Keywords

physiologic pacing, ventricular pacing, hospitalizations

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

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

Arm Title

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Dual chamber cardiac pacemaker

Intervention Description

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

Intervention Name(s)

Single chamber cardiac pacemaker

Intervention Description

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

Primary Outcome Measure Information:

Title

To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes

Time Frame

approximately 3 - 5 years

Secondary Outcome Measure Information:

Title

To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life

Time Frame

approximately 3 - 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: