Spritely: Syncope: Pacing or Recording in the Later Years

Sponsor

Canadian Institutes of Health Research (CIHR) (Other)

Overall Status

Completed

CT.gov ID

NCT01423994

Collaborator

Vanderbilt University (Other)

120

Enrollment

Locations

Arms

Duration (Months)

7.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2011

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period. [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

Secondary outcome measures will include total number of syncopal spells. [2 years]
Secondary outcome measures will include the likelihood of a first recurrence of syncope. [2 years]
Secondary outcome measures will include the physical trauma due to syncope. [2 years]
Secondary outcome measures will include quality of life of the participants. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University	Nashville	Tennessee	United States	37232
2	University of Calgary	Calgary	Alberta	Canada	T2N 4Z6
3	Royal Alexandra Hospital	Edmonton	Alberta	Canada	T6G 1K8
4	Victoria Heart Institute	Victoria	British Columbia	Canada	V8R 4R2
5	St. Boniface Hospital	Winnipeg	Manitoba	Canada	R2H 2A6
6	Horizon Health Network New Brunswick	Saint John	New Brunswick	Canada	E2L 4L2
7	Mc Master University	Hamilton	Ontario	Canada	L8L 8E7
8	Queen's University	Kingston	Ontario	Canada	K7L 3N6
9	London Health Sciences Centre	London	Ontario	Canada	N6A 3K7
10	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8
11	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4
12	Prairie Vascular Research Inc.	Regina	Saskatchewan	Canada	S4P 0W5
13	University of Occupational and Environmental Health	Kitakyushu		Japan
14	Shwa General Hospital	Saitama		Japan
15	University Malaya Medical Centre	Kuala Lumpur		Malaysia
16	Kings College Hospital	London		United Kingdom
17	James Cook University Hospital	Middlesbrough		United Kingdom