Syncope: Pacing or Recording in the Later Years

NCT ID: NCT01423994

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-11-01

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.

Conditions

Syncope; Heart Block; Conduction Disorder of the Heart

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

implantable loop recorder

Group Type: ACTIVE_COMPARATOR

implantable loop recorder

Intervention Type: 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.

pacemaker

Group Type: ACTIVE_COMPARATOR

pacemaker

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Bob Sheldon

Professor of Cardiac Sciences, Medicine and Medical Genetics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert S Sheldon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Vanderbilt University

Nashville, Tennessee, United States

University of Calgary

Calgary, Alberta, Canada

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Victoria Heart Institute

Victoria, British Columbia, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Horizon Health Network New Brunswick

Saint John, New Brunswick, 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

Prairie Vascular Research Inc.

Regina, Saskatchewan, Canada

University of Occupational and Environmental Health

Kitakyushu, , Japan

Shwa General Hospital

Saitama, , Japan

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Kings College Hospital

London, , United Kingdom

James Cook University Hospital

Middlesbrough, , United Kingdom

Countries

United States; Canada; Japan; Malaysia; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35210082 (View on PubMed)

Other Identifiers

CIHR#230880

Identifier Type: -

Identifier Source: org_study_id