Syncope: Pacing or Recording in the Later Years

Completed · Phase 4

Conditions studied: Syncope, Heart Block, Conduction Disorder of the Heart

In brief

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.

Key facts

Study ID

NCT01423994

Run by

Canadian Institutes of Health Research (CIHR)

People needed

120

Starts

2011-08-01

Expected to finish

2017-11-01

Last updated by the study team

2019-05-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients are eligible if they have:
• >1 syncopal spell within 1 year preceding enrollment, and
• bifascicular block on a 12-lead ECG, and
• Age > 50 years and
• written informed consent. Syncope will be defined based on history using a standardized form.

You may not qualify if…

• Patients will be excluded if they have criteria related to study strategies, including:
• previous pacemaker, ICD, or Implantable Loop Recorder in situ,
• ACC/AHA/HRS Class I indication for permanent pacing or ICD implantation,
• left ventricular ejection fraction < 35% mandating ICD therapy,
• contra-indication to a transvenous pacemaker such as artificial tricuspid valve or active sepsis.
• Patients will also be excluded if a potential competing cause of syncope poses a threat to life, such as:
• hypertrophic cardiomyopathy,
• documented sustained ventricular tachycardia or
• inducible, sustained monomorphic ventricular tachycardia on EP study.
• They will be excluded if they have:
• a history of myocardial infarction within 3 months prior to enrollment, and
• a major chronic co-morbid medical condition that would preclude 24 months of follow-up.

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States
• University of Calgary — Calgary, Alberta, Canada
• Royal Alexandra Hospital — Edmonton, Alberta, Canada
• Victoria Heart Institute — Victoria, British Columbia, Canada
• St. Boniface Hospital — Winnipeg, Manitoba, Canada
• Horizon Health Network New Brunswick — Saint John, New Brunswick, Canada
• Mc Master University — Hamilton, Ontario, Canada
• Queen's University — Kingston, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada
• Prairie Vascular Research Inc. — Regina, Saskatchewan, Canada
• University of Occupational and Environmental Health — Kitakyushu, Japan
• Shwa General Hospital — Saitama, Japan
• University Malaya Medical Centre — Kuala Lumpur, Malaysia
• Kings College Hospital — London, United Kingdom
• James Cook University Hospital — Middlesbrough, United Kingdom

Full record on ClinicalTrials.gov

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