Syncope: Pacing or Recording in the Later Years

Phase 4

Completed

• Conditions: Syncope; Conduction Disorder of the Heart; Heart Block
• Interventions: Procedure: implantable loop recorder; Procedure: pacemaker

• Registration Number: NCT01423994
• Lead Sponsor: Canadian Institutes of Health Research (CIHR)

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Primary Completion: 2017-05
• Study Completion: 2017-11-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
implantable loop recorder	implantable loop recorder	-
pacemaker	pacemaker	-

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period.	2 years	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

Name	Time	Method
Secondary outcome measures will include the likelihood of a first recurrence of syncope.	2 years
Secondary outcome measures will include the physical trauma due to syncope.	2 years
Secondary outcome measures will include total number of syncopal spells.	2 years
Secondary outcome measures will include quality of life of the participants.	2 years

Trial Locations

Locations (17)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, 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

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

University of Occupational and Environmental Health; 🇯🇵 Kitakyushu, Japan

Shwa General Hospital; 🇯🇵 Saitama, Japan

Kings College Hospital; 🇬🇧 London, United Kingdom

James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom

Victoria Heart Institute; 🇨🇦 Victoria, British Columbia, Canada

Horizon Health Network New Brunswick; 🇨🇦 Saint John, New Brunswick, Canada

Prairie Vascular Research Inc.; 🇨🇦 Regina, Saskatchewan, Canada

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

University of Calgary; 🇨🇦 Calgary, Alberta, Canada