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Syncope: Pacing or Recording in the Later Years

NCT01423994 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-05-16

No results posted yet for this study

Summary

Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits, and probably is responsible for CDN $250 million in health care spending each year. It is associated with decreased quality of life, trauma, loss of employment, and limitations in daily activities. It is a particular problem for older people, partly because of increased frailty, and partly because of a difficult differential diagnosis. One of the causes in older adults is intermittent complete heart block in the setting of bifascicular heart block, but they may also faint due to a variety of tachyarrhythmias, sick sinus syndrome, and several neurally mediated syncopes. Often treatment decisions should be made before the true cause is apparent.

Conditions

  • Syncope
  • Heart Block
  • Conduction Disorder of the Heart

Interventions

PROCEDURE

pacemaker

A single or dual chamber pacemaker will be implanted according to the manufacturer's instructions for use with standard techniques. Either a single or dual chamber pacemaker will be permitted according to local practice unless the patient is in chronic or persistent atrial fibrillation, in which case a single chamber pacemaker will be used. The pacemaker configuration will be at the discretion of the investigator. Single chamber ventricular pacemakers will be programmed to activity responsiveness off in VVI mode, rates 50-120 bpm. Dual chamber pacemaker programming will be to DDD mode (50-120) with mode switch on.

PROCEDURE

implantable loop recorder

The implantable loop recorder will be programmed for automatic detection using settings of Low Heart Rate \<50 bpm, High Heart Rate \>165 bpm, and Pause \> 3 seconds.

Sponsors & Collaborators

  • Vanderbilt University

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    lead OTHER_GOV

Principal Investigators

  • Robert S Sheldon, MD, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2017-05-31
Completion
2017-11-01

Countries

  • United States
  • Canada
  • Japan
  • Malaysia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01423994 on ClinicalTrials.gov