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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Block; Syncope; Conduction Disorder of the Heart
• Intervention / Treatment: Procedure: implantable loop recorder; Procedure: pacemaker

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 1K8
      • Royal Alexandra Hospital
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 4R2
      • Victoria Heart Institute
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Horizon Health Network New Brunswick
  • Ontario
    • Hamilton, Ontario, Canada, L8L 8E7
      • Mc Master University
    • Kingston, Ontario, Canada, K7L 3N6
      • Queen's University
    • London, Ontario, Canada, N6A 3K7
      • London Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • Prairie Vascular Research Inc.
• Japan
  • Kitakyushu, Japan
    • University of Occupational and Environmental Health
  • Saitama, Japan
    • Shwa General Hospital
• Malaysia
  • Kuala Lumpur, Malaysia
    • University Malaya Medical Centre
• United Kingdom
  • London, United Kingdom
    • Kings College Hospital
  • Middlesbrough, United Kingdom
    • James Cook University Hospital
• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: implantable loop recorder	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.
ACTIVE_COMPARATOR: pacemaker	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Canadian Institutes of Health Research (CIHR)
• Collaborators: Vanderbilt University
• Investigators: Principal Investigator: Robert S Sheldon, MD, PhD, University of Calgary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: August 22, 2011
• First Submitted That Met QC Criteria: August 25, 2011
• First Posted (ESTIMATE): August 26, 2011

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: syncope; pacemaker; fainting; implantable loop recorder; heart block; bifascicular heart block
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Unconsciousness; Consciousness Disorders; Heart Block; Syncope; Cardiac Conduction System Disease
• Other Study ID Numbers: CIHR#230880