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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary
ClinicalTrials.gov Identifier:
NCT01423994
First received: August 22, 2011
Last updated: May 21, 2015
Last verified: May 2015
  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:


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: May 2017
Estimated Primary Completion Date: May 2017 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423994

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T6G 1K8
Canada, British Columbia
Victoria Heart Institute
Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Horizon Health Network New Brunswick
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Mc Master University
Hamilton, Ontario, Canada, L8L 8E7
Queen's University
Kingston, Ontario, Canada, K7L 3N6
London Health Sciences Centre
London, Ontario, Canada, N6A 3K7
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Prairie Vascular Research Inc.
Regina, Saskatchewan, Canada, S4P 0W5
Japan
University of Occupational and Environmental Health
Kitakyushu, Japan
Shwa General Hospital
Saitama, Japan
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
United Kingdom
Kings College Hospital
London, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
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: May 21, 2015
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:
Syncope
Arrhythmias, Cardiac
Heart Block
Cardiovascular Diseases
Consciousness Disorders
Heart Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Unconsciousness

ClinicalTrials.gov processed this record on May 29, 2015