Syncope: Pacing or Recording in the Later Years (Spritely)
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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) |
- 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 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 |
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.
Contacts and Locations| Contact: Robert S Sheldon, MD, PhD | 403-220-8191 | sheldon@ucalgary.ca |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Satish Raj, MD 615-343-6499 satish.raj@vanderbilt.edu | |
| Principal Investigator: Satish Raj, MD | |
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Contact: Robert S Sheldon, MD, PhD 403-220-8191 sheldon@ucalgary.ca | |
| Principal Investigator: Robert Sheldon, MD | |
| Royal Alexandra Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 1K8 | |
| Contact: Randall Williams, MD | |
| Principal Investigator: Randall Williams, MD | |
| Canada, British Columbia | |
| Victoria Heart Institute | Recruiting |
| Victoria, British Columbia, Canada, V8R 4R2 | |
| Contact: Tony Tang, MD 250-595-0400 | |
| Principal Investigator: Tony Tang, MD | |
| Canada, Manitoba | |
| St. Boniface Hospital | Recruiting |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Contact: Colette Seiffer, MD 204-233-8563 ext 1267 | |
| Principal Investigator: Colette Seiffer, MD | |
| Canada, New Brunswick | |
| Horizon Health Network New Brunswick | Recruiting |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Contact: Satish Toal, MD 506-648-7459 | |
| Principal Investigator: Satish Toal, MD | |
| Canada, Ontario | |
| Mc Master University | Recruiting |
| Hamilton, Ontario, Canada, L8L 8E7 | |
| Contact: Carlos Morillo, MD 905-527-4322 ext 44450 | |
| Principal Investigator: Carlos Morillo, MD | |
| Queen's University | Recruiting |
| Kingston, Ontario, Canada, K7L 3N6 | |
| Contact: Adrian Baranchuk, MD 613-549-6666 | |
| Principal Investigator: Adrian Baranchuk, MD | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 3K7 | |
| Contact: Raymond Yee, MD | |
| Principal Investigator: Raymond Yee, MD | |
| Canada, Quebec | |
| Montreal Heart Institute | Recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Contact: Mario Talajic, MD 514-376-3330 | |
| Principal Investigator: Mario Talajic, MD | |
| Centre Hospitalier Universitaire de Sherbrooke | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: Felix Ayala-Paredes, MD 819-346-1110 ext 74947 | |
| Contact: Claude Jean 819-346-1110 ext 16317 | |
| Principal Investigator: Felix Ayala-Paredes, MD | |
| 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 16, 2013 |
| 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 16, 2013