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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Calgary
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: June 24, 2014
Last verified: June 2014

August 22, 2011
June 24, 2014
August 2011
December 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01423994 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Syncope: Pacing or Recording in the Later Years
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Syncope
  • Heart Block
  • Conduction Disorder of the Heart
  • 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.

  • 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: implantable loop recorder
    Intervention: Procedure: implantable loop recorder
  • Active Comparator: pacemaker
    Intervention: Procedure: pacemaker
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Robert S Sheldon, MD, PhD 403-220-8191 sheldon@ucalgary.ca
United States,   Canada,   Japan,   Malaysia,   United Kingdom
 
NCT01423994
CIHR#230880
Yes
Dr. Bob Sheldon, University of Calgary
Canadian Institutes of Health Research (CIHR)
Vanderbilt University
Principal Investigator: Robert S Sheldon, MD, PhD University of Calgary
University of Calgary
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP