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Syncope: Pacing or Recording in the Later Years (Spritely)
This study is currently recruiting participants.
Verified April 2012 by University of Calgary

First Received on August 22, 2011.   Last Updated on April 3, 2012   History of Changes
Sponsor: Canadian Institutes of Health Research (CIHR)
Collaborator: Vanderbilt University
Information provided by (Responsible Party): Dr. Bob Sheldon, University of Calgary
ClinicalTrials.gov Identifier: NCT01423994
  Purpose

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.


Condition Intervention Phase
Syncope
Heart Block
Conduction Disorder of the Heart
 Procedure: pacemaker
Procedure: implantable loop recorder
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Syncope: Pacing or Recording in the Later Years (SPRITELY)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Fainting
U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Secondary outcome measures will include the likelihood of a first recurrence of syncope. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Secondary outcome measures will include the physical trauma due to syncope. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Secondary outcome measures will include quality of life of the participants. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423994

Contacts
Contact: Robert S Sheldon, MD, PhD 403-220-8191 sheldon@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Robert S Sheldon, MD, PhD     403-220-8191     sheldon@ucalgary.ca    
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T6G 1K8
Contact: Randall Williams, MD            
Canada, British Columbia
Victoria Heart Institute Recruiting
Victoria, British Columbia, Canada, V8R 4R2
Contact: Tony Tang, MD     250-595-0400        
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Colette Seiffer, MD     204-233-8563 ext 1267        
Canada, Ontario
Mc Master University Recruiting
Hamilton, Ontario, Canada, L8L 8E7
Contact: Carlos Morillo, MD     905-527-4322 ext 44450        
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Mario Talajic, MD     514-376-3330        
Sponsors and Collaborators
Canadian Institutes of Health Research (CIHR)
Vanderbilt University
Investigators
Principal Investigator: Robert S Sheldon, MD, PhD University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Bob Sheldon, Professor of Cardiac Sciences, Medicine and Medical Genetics, University of Calgary
ClinicalTrials.gov Identifier: NCT01423994     History of Changes
Other Study ID Numbers: CIHR#230880
Study First Received: August 22, 2011
Last Updated: April 3, 2012
Health Authority: Canada: Health Canada
United States: Institutional Review Board

Keywords provided by University of Calgary:
syncope
fainting
implantable loop recorder
 pacemaker
heart block
bifascicular heart block

Additional relevant MeSH terms:
Heart Block
Syncope
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2012



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