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

Primary Purpose

Syncope, Heart Block, Conduction Disorder of the Heart

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
pacemaker
implantable loop recorder
Sponsored by
Canadian Institutes of Health Research (CIHR)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syncope focused on measuring syncope, fainting, implantable loop recorder, pacemaker, heart block, bifascicular heart block

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University
  • University of Calgary
  • Royal Alexandra Hospital
  • Victoria Heart Institute
  • St. Boniface Hospital
  • Horizon Health Network New Brunswick
  • Mc Master University
  • Queen's University
  • London Health Sciences Centre
  • Montreal Heart Institute
  • Centre Hospitalier Universitaire de Sherbrooke
  • Prairie Vascular Research Inc.
  • University of Occupational and Environmental Health
  • Shwa General Hospital
  • University Malaya Medical Centre
  • Kings College Hospital
  • James Cook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

implantable loop recorder

pacemaker

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2011
Last Updated
May 15, 2019
Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01423994
Brief Title
Syncope: Pacing or Recording in the Later Years
Acronym
Spritely
Official Title
Syncope: Pacing or Recording in the Later Years (SPRITELY)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborators
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Heart Block, Conduction Disorder of the Heart
Keywords
syncope, fainting, implantable loop recorder, pacemaker, heart block, bifascicular heart block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
implantable loop recorder
Arm Type
Active Comparator
Arm Title
pacemaker
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
pacemaker
Intervention Description
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
Intervention Name(s)
implantable loop recorder
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Secondary outcome measures will include total number of syncopal spells.
Time Frame
2 years
Title
Secondary outcome measures will include the likelihood of a first recurrence of syncope.
Time Frame
2 years
Title
Secondary outcome measures will include the physical trauma due to syncope.
Time Frame
2 years
Title
Secondary outcome measures will include quality of life of the participants.
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Sheldon, MD, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1K8
Country
Canada
Facility Name
Victoria Heart Institute
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Horizon Health Network New Brunswick
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Mc Master University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 8E7
Country
Canada
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Prairie Vascular Research Inc.
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada
Facility Name
University of Occupational and Environmental Health
City
Kitakyushu
Country
Japan
Facility Name
Shwa General Hospital
City
Saitama
Country
Japan
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Kings College Hospital
City
London
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35210082
Citation
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.
Results Reference
derived

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Syncope: Pacing or Recording in the Later Years

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