Clinical Trial: Syncope: Pacing or Recording in the Later Years
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Syncope: Pacing or Recording in the Later Years (SPRITELY)
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 Summary: 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.
Sponsor: Canadian Institutes of Health Research (CIHR)
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Secondary outcome measures will include total number of syncopal spells. [ Time Frame: 2 years ]
- Secondary outcome measures will include the likelihood of a first recurrence of syncope. [ Time Frame: 2 years ]
- Secondary outcome measures will include the physical trauma due to syncope. [ Time Frame: 2 years ]
- Secondary outcome measures will include quality of life of the participants. [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: University of Calgary
Dates:
Date Received: August 22, 2011
Date Started: August 2011
Date Completion: May 2017
Last Updated: August 29, 2016
Last Verified: August 2016