Overview

This trial is active, not recruiting.

Conditions syncope, heart block, conduction disorder of the heart
Treatments pacemaker, implantable loop recorder
Phase phase 4
Sponsor Canadian Institutes of Health Research (CIHR)
Collaborator Vanderbilt University
Start date August 2011
End date May 2017
Trial size 120 participants
Trial identifier NCT01423994, CIHR#230880

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

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: 1. previous pacemaker, ICD, or Implantable Loop Recorder in situ, 2. ACC/AHA/HRS Class I indication for permanent pacing or ICD implantation, 3. left ventricular ejection fraction < 35% mandating ICD therapy, 4. 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: 5. hypertrophic cardiomyopathy, 6. documented sustained ventricular tachycardia or 7. inducible, sustained monomorphic ventricular tachycardia on EP study. -They will be excluded if they have: 8. a history of myocardial infarction within 3 months prior to enrollment, and 9. a major chronic co-morbid medical condition that would preclude 24 months of follow-up.

Additional Information

Official title Syncope: Pacing or Recording in the Later Years (SPRITELY)
Principal investigator Robert S Sheldon, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Calgary.