Status:
COMPLETED
Syncope: Pacing or Recording in the Later Years
Lead Sponsor:
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsors:
Vanderbilt University
Conditions:
Syncope
Heart Block
Eligibility:
All Genders
Phase:
PHASE4
Brief 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 d...
Detailed Description
There are two general approaches to the patient with syncope and bifascicular block, a common substrate for intermittent heart block. The first is to assume that intermittent heart block is the cause,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01423994
Start Date
August 1 2011
End Date
November 1 2017
Last Update
May 16 2019
Active Locations (17)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232
2
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
3
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T6G 1K8
4
Victoria Heart Institute
Victoria, British Columbia, Canada, V8R 4R2