Syncope: Pacing or Recording in the Later Years (SPRITELY)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Syncope
- Sponsor
- Canadian Institutes of Health Research (CIHR)
- Enrollment
- 120
- Locations
- 17
- Primary Endpoint
- The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 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.
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, and simply implant a pacemaker. The second is to implant a digital ECG loop recorder with a lifespan of 2 - 3 years, determine the rhythm abnormalities during the next faint, and treat accordingly. Both approaches expose patients to a risk of fainting and its sequelae, and both carry device-related complications.Which approach is superior is unknown.
Investigators
Dr. Bob Sheldon
Professor of Cardiac Sciences, Medicine and Medical Genetics
University of Calgary
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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:
Outcomes
Primary Outcomes
The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period.
Time Frame: 2 years
MASRE will capture the major consequences ensuing from both strategies, including 1) syncope, 2) symptomatic bradycardias, 3) asymptomatic complete heart block, 4) acute and chronic pacemaker and ILR complications, and 5) death.
Secondary Outcomes
- Secondary outcome measures will include the likelihood of a first recurrence of syncope.(2 years)
- Secondary outcome measures will include the physical trauma due to syncope.(2 years)
- Secondary outcome measures will include total number of syncopal spells.(2 years)
- Secondary outcome measures will include quality of life of the participants.(2 years)