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

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ClinicalTrials.gov Identifier: NCT01423994
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : May 16, 2019
Vanderbilt University
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Syncope: Pacing or Recording in the Later Years (SPRITELY)
Study Start Date : August 2011
Actual Primary Completion Date : May 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

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.

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Secondary outcome measures will include total number of syncopal spells. [ Time Frame: 2 years ]
  2. Secondary outcome measures will include the likelihood of a first recurrence of syncope. [ Time Frame: 2 years ]
  3. Secondary outcome measures will include the physical trauma due to syncope. [ Time Frame: 2 years ]
  4. Secondary outcome measures will include quality of life of the participants. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423994

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Sponsors and Collaborators
Canadian Institutes of Health Research (CIHR)
Vanderbilt University
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Principal Investigator: Robert S Sheldon, MD, PhD University of Calgary
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Bob Sheldon, Professor of Cardiac Sciences, Medicine and Medical Genetics, University of Calgary
ClinicalTrials.gov Identifier: NCT01423994    
Other Study ID Numbers: CIHR#230880
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Keywords provided by Dr. Bob Sheldon, University of Calgary:
implantable loop recorder
heart block
bifascicular heart block
Additional relevant MeSH terms:
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Heart Block
Cardiac Conduction System Disease
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes