Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope (BIOSync CLS)
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|ClinicalTrials.gov Identifier: NCT02324920|
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Syncope||Device: DDD-CLS Device: ODO||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||April 2020|
|Actual Study Completion Date :||July 2020|
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
Placebo Comparator: ODO
The pacemaker will be programmed in ODO mode.
- Time to the first recurrence of syncopal episode [ Time Frame: 24 months ]
- Time to the first recurrence of pre-syncope or syncope, whichever comes first [ Time Frame: 24 months ]
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): NCT02324920