NCT01423994

Syncope: Pacing or Recording in the Later Years

Syncope: Pacing or Recording in the Later Years (SPRITELY)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Canadian Institutes of Health Research (CIHR) · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Syncope
• Heart Block
• Conduction Disorder of the Heart

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2017-05-01
• Completion: 2017-11-01
• First posted: 2011-08-26
• Last updated: 2019-05-16

Locations

17 sites across 5 countries: United States, Canada, Japan, Malaysia, United Kingdom