Syncope: Pacing or Recording in the Later Years (Spritely)
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.
Conduction Disorder of the Heart
Procedure: implantable loop recorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Syncope: Pacing or Recording in the Later Years (SPRITELY)|
- 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 ] [ Designated as safety issue: Yes ]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 outcome measures will include total number of syncopal spells. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Secondary outcome measures will include the likelihood of a first recurrence of syncope. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Secondary outcome measures will include the physical trauma due to syncope. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Secondary outcome measures will include quality of life of the participants. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
|Active Comparator: implantable loop recorder||
Procedure: implantable loop recorder
The implantable loop recorder will be programmed for automatic detection using settings of Low Heart Rate <50 bpm, High Heart Rate >165 bpm, and Pause > 3 seconds.
|Active Comparator: pacemaker||
A single or dual chamber pacemaker will be implanted according to the manufacturer's instructions for use with standard techniques.
Either a single or dual chamber pacemaker will be permitted according to local practice unless the patient is in chronic or persistent atrial fibrillation, in which case a single chamber pacemaker will be used. The pacemaker configuration will be at the discretion of the investigator.
Single chamber ventricular pacemakers will be programmed to activity responsiveness off in VVI mode, rates 50-120 bpm.
Dual chamber pacemaker programming will be to DDD mode (50-120) with mode switch on.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423994
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|University of Calgary|
|Calgary, Alberta, Canada, T2N 4Z6|
|Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T6G 1K8|
|Canada, British Columbia|
|Victoria Heart Institute|
|Victoria, British Columbia, Canada, V8R 4R2|
|St. Boniface Hospital|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Canada, New Brunswick|
|Horizon Health Network New Brunswick|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Mc Master University|
|Hamilton, Ontario, Canada, L8L 8E7|
|Kingston, Ontario, Canada, K7L 3N6|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 3K7|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Prairie Vascular Research Inc.|
|Regina, Saskatchewan, Canada, S4P 0W5|
|University of Occupational and Environmental Health|
|Shwa General Hospital|
|University Malaya Medical Centre|
|Kuala Lumpur, Malaysia|
|Kings College Hospital|
|London, United Kingdom|
|James Cook University Hospital|
|Middlesbrough, United Kingdom|
|Principal Investigator:||Robert S Sheldon, MD, PhD||University of Calgary|