Syncope: Pacing or Recording in the Later Years

NCT01423994 | Completed Phase 4 DMC

• 1 other identifier: CIHR#230880
• Study Type: interventional
• Target: 120
• Locations: 5 countries
• Sites: 17

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.

Conditions

Syncope; Heart Block; Conduction Disorder of the Heart

Keywords

syncope; fainting; implantable loop recorder; pacemaker; heart block; bifascicular heart block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Secondary outcome measures will include total number of syncopal spells.

  2 years

• 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 quality of life of the participants.

  2 years

Study Arms (2)

implantable loop recorder

ACTIVE COMPARATOR

Procedure: implantable loop recorder

pacemaker

ACTIVE COMPARATOR

Procedure: pacemaker

Interventions

pacemaker PROCEDURE

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.

pacemaker

implantable loop recorder PROCEDURE

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.

implantable loop recorder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): lead
• Vanderbilt University: collaborator

Study Sites (17)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T6G 1K8, Canada

Location

Victoria Heart Institute

Victoria, British Columbia, V8R 4R2, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Horizon Health Network New Brunswick

Saint John, New Brunswick, E2L 4L2, Canada

Location

Mc Master University

Hamilton, Ontario, L8L 8E7, Canada

Location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 3K7, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Prairie Vascular Research Inc.

Regina, Saskatchewan, S4P 0W5, Canada

Location

University of Occupational and Environmental Health

Kitakyushu, Japan

Location

Shwa General Hospital

Saitama, Japan

Location

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Kings College Hospital

London, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35210082 DERIVED

MeSH Terms

Conditions

Syncope; Heart Block; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes

Study Officials

• Robert S Sheldon, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiac Sciences, Medicine and Medical Genetics

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 26, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

JP (2); US (1); GB (2); MY (1); CA (11)