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 ]

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.


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