Syncope: Pacing or Recording in the Later Years (Spritely)
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|ClinicalTrials.gov Identifier: NCT01423994|
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Syncope Heart Block Conduction Disorder of the Heart||Procedure: pacemaker Procedure: implantable loop recorder||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Syncope: Pacing or Recording in the Later Years (SPRITELY)|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||November 1, 2017|
|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||
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.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423994
|Principal Investigator:||Robert S Sheldon, MD, PhD||University of Calgary|