Syncope: Pacing or Recording in the Later Years

Syncope Clinical Trial

— Spritely  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423994
• Other study ID #: CIHR#230880
• Status: Completed
• Phase: Phase 4
• Start date: August 2011
• Est. completion date: November 1, 2017

Study information

• Verified date: May 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 1, 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Conduction Disorder of the Heart
• Heart Block
• Syncope

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Mc Master University	Hamilton	Ontario
Canada	Queen's University	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Prairie Vascular Research Inc.	Regina	Saskatchewan
Canada	Horizon Health Network New Brunswick	Saint John	New Brunswick
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Victoria Heart Institute	Victoria	British Columbia
Canada	St. Boniface Hospital	Winnipeg	Manitoba
Japan	University of Occupational and Environmental Health	Kitakyushu
Japan	Shwa General Hospital	Saitama
Malaysia	University Malaya Medical Centre	Kuala Lumpur
United Kingdom	Kings College Hospital	London
United Kingdom	James Cook University Hospital	Middlesbrough
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Institutes of Health Research (CIHR)	Vanderbilt University

Countries where clinical trial is conducted

United States,  Canada,  Japan,  Malaysia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period.	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.	2 years
Secondary	Secondary outcome measures will include total number of syncopal spells.		2 years
Secondary	Secondary outcome measures will include the likelihood of a first recurrence of syncope.		2 years
Secondary	Secondary outcome measures will include the physical trauma due to syncope.		2 years
Secondary	Secondary outcome measures will include quality of life of the participants.		2 years