Clinical trial NCT01423994: Syncope: Pacing or Recording in the Later Years
Official title: Syncope: Pacing or Recording in the Later Years (SPRITELY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Syncope
Heart Block
Conduction Disorder of the Heart
Keywords: syncope
fainting
implantable loop recorder
pacemaker
heart block
bifascicular heart block
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2011-08-26
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period.
timeFrame: 2 years
Secondary outcomes:
measure: Secondary outcome measures will include total number of syncopal spells.
timeFrame: 2 years
measure: Secondary outcome measures will include the likelihood of a first recurrence of syncope.
timeFrame: 2 years
measure: Secondary outcome measures will include the physical trauma due to syncope.
timeFrame: 2 years
measure: Secondary outcome measures will include quality of life of the participants.
timeFrame: 2 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Victoria
country: Canada
facility: Victoria Heart Institute
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Saint John
country: Canada
facility: Horizon Health Network New Brunswick
state: New Brunswick
city: Hamilton
country: Canada
facility: Mc Master University
state: Ontario
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Regina
country: Canada
facility: Prairie Vascular Research Inc.
state: Saskatchewan
city: Kitakyushu
country: Japan
facility: University of Occupational and Environmental Health
city: Saitama
country: Japan
facility: Shwa General Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: London
country: United Kingdom
facility: Kings College Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: University of Calgary
name: Robert S Sheldon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheldon R, Talajic M, Tang A, Becker G, Essebag V, Sultan O, Baranchuk A, Ritchie D, Morillo C, Krahn A, Brignole M, Manns B, Maxey C, Raj SR; SPRITELY Investigators. Randomized Pragmatic Trial of Pacemaker Versus Implantable Cardiac Monitor in Syncope and Bifascicular Block. JACC Clin Electrophysiol. 2022 Feb;8(2):239-248. doi: 10.1016/j.jacep.2021.10.003. Epub 2021 Nov 24.