NCT00116987

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

5.1 years

First QC Date

June 30, 2005

Last Update Submit

June 11, 2015

Conditions

Atrial FibrillationCardiac Pacing, Artificial

Keywords

physiologic pacingventricular pacinghospitalizations

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    approximately 3 - 5 years

Study Arms (2)

1

OTHER

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

Device: Dual chamber cardiac pacemaker

2

OTHER

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

Device: Single chamber cardiac pacemaker

Interventions

Dual chamber cardiac pacemakerDEVICE

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

1
Single chamber cardiac pacemakerDEVICE

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

2

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age and older
  • Symptomatic bradycardia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne M Gillis, MD

    Director of Pacing and Electrophysiology, Professor of Medicine, University of Calgary

    PRINCIPAL INVESTIGATOR

  • Derek V Exner, MD, MPH

    University of Calgary

    STUDY DIRECTOR

  • D. George Wyse, MD, PhD

    University of Calgary

    STUDY DIRECTOR

  • L. Brent Mitchell, MD

    University of Calgary

    STUDY DIRECTOR

  • Robert S Sheldon, MD, Ph D

    University of Calgary

    STUDY DIRECTOR

  • John M Rothschild, MD

    University of Calgary

    STUDY DIRECTOR

  • Henry J Duff, MD

    University of Calgary

    STUDY DIRECTOR

  • John Burgess, MD

    University of Calgary

    STUDY DIRECTOR

  • Alexander Bayes, MD

    University of Calgary

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, University of Calgary

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 1, 2005

Study Start

August 1, 2003

Primary Completion

September 1, 2008

Study Completion

November 1, 2009

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations

CA(1)