SyncopePhase 4SpritelyNCT01423994
Syncope: Pacing or Recording in the Later Years
A Phase 4 study testing pacemaker and implantable loop recorder in people with Syncope and Heart Block, run by Canadian Institutes of Health Research (CIHR) at 17 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Syncope, Heart Block, Conduction Disorder of the Heart
- What is being tested?
- pacemaker and implantable loop recorder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Aug 2011to 1 Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- -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:
Show all 12Show fewer
- 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.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Canada11 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
Royal Alexandra Hospital
Edmonton, Alberta, T6G 1K8
Mc Master University
Hamilton, Ontario, L8L 8E7
Queen's University
Kingston, Ontario, K7L 3N6
London Health Sciences Centre
London, Ontario, N6A 3K7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Prairie Vascular Research Inc.
Regina, Saskatchewan, S4P 0W5
Horizon Health Network New Brunswick
Saint John, New Brunswick, E2L 4L2
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Victoria Heart Institute
Victoria, British Columbia, V8R 4R2
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Japan2 sites
University of Occupational and Environmental Health
Kitakyushu
Shwa General Hospital
Saitama
United Kingdom2 sites
Kings College Hospital
London
James Cook University Hospital
Middlesbrough
About this study
Official title: 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.
Read the 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.
- Conditions
- Syncope, Heart Block, Conduction Disorder of the Heart
- Being tested
- pacemaker, implantable loop recorder
- Keywords
- syncope, fainting, implantable loop recorder, pacemaker, heart block, bifascicular heart block
- Medical subject headings
- Syncope, Heart Block, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemakerProcedure or surgery
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.
implantable loop recorderProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| implantable loop recorder | Active comparator | Not described Receives: Procedure: implantable loop recorder |
| pacemaker | Active comparator | Not described Receives: Procedure: pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period.
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.
Measured: 2 years
Secondary outcomes (4)
Secondary outcome measures will include total number of syncopal spells.
Measured: 2 years
Secondary outcome measures will include the likelihood of a first recurrence of syncope.
Measured: 2 years
Secondary outcome measures will include the physical trauma due to syncope.
Measured: 2 years
Secondary outcome measures will include quality of life of the participants.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Institutes of Health Research (CIHR)
- Sponsor type
- Other government
- Collaborators
- Vanderbilt University
- Responsible party
- Principal investigator, Dr. Bob Sheldon, University of Calgary
- Investigators
- Robert S Sheldon, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423994
- Sponsor's protocol ID
- CIHR#230880
- Acronym
- Spritely
- Status last verified
- May 2019
- First submitted
- 22 Aug 2011
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sheldon R, Talajic M, Tang A, Becker G, Essebag V, Sultan O, Baranchuk A, Ritchie D, Morillo C, Krahn A, Brignole M, Manns B, Maxey C, Raj SR; SPRITELY Investigators. Randomized Pragmatic Trial of Pacemaker Versus Implantable Cardiac Monitor in Syncope and Bifascicular Block. JACC Clin Electrophysiol. 2022 Feb;8(2):239-248. doi: 10.1016/j.jacep.2021.10.003. Epub 2021 Nov 24.
PubMed 35210082
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syncope: Pacing or Recording in the Later Years (SPRITELY)
- ClinicalTrials.gov ID
- NCT01423994
- Acronym / sponsor ID
- Spritely / CIHR#230880
- Conditions
- Syncope, Heart Block, Conduction Disorder of the Heart
- Keywords
- syncope, fainting, implantable loop recorder, pacemaker, heart block, bifascicular heart block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Canadian Institutes of Health Research (CIHR)Other government
- Collaborators
- Vanderbilt University
- Study start
- Aug 2011
- Primary completion
- May 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implantable loop recorder | Active comparator | Procedure: implantable loop recorder |
| pacemaker | Active comparator | Procedure: pacemaker |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- >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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pacemakerA 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 or surgery | pacemaker |
| implantable loop recorderThe 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. | Procedure or surgery | implantable loop recorder |
Primary outcome
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.
4 secondary outcomes
Secondary outcome measures will include total number of syncopal spells.
Time frame: 2 years
Secondary outcome measures will include the likelihood of a first recurrence of syncope.
Time frame: 2 years
Secondary outcome measures will include the physical trauma due to syncope.
Time frame: 2 years
Secondary outcome measures will include quality of life of the participants.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Derived from this study: PubMed 35210082Sheldon R, Talajic M, Tang A, Becker G, Essebag V, Sultan O, Baranchuk A, Ritchie D, Morillo C, Krahn A, Brignole M, Manns B, Maxey C, Raj SR; SPRITELY Investigators. Randomized Pragmatic Trial of Pacemaker Versus Implantable Cardiac Monitor in Syncope and Bifascicular Block. JACC Clin Electrophysiol. 2022 Feb;8(2):239-248. doi: 10.1016/j.jacep.2021.10.003. Epub 2021 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Sheldon, MD, PhD principal investigator
University of Calgary
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pacemaker and implantable loop recorder in people with Syncope and Heart Block, run by Canadian Institutes of Health Research (CIHR) at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada, Japan, United Kingdom, United States, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01423994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.