At a glance
ClinicalIndex Comparison RecordN/ACompleted· 128 enrolled
Drug / intervention
DDD-CLS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.
In Brief
A clinical study evaluating DDD-CLS and ODO for Syncope. Completed, enrolled 128 participants across 24 sites in 6 countries.
Detailed Summary
The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSyncope
CountriesCanada, France, Italy, Netherlands, Portugal, Spain
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartOct 2015
Primary CompletionApr 2020
Study CompletionJul 2020
TodayJul 2026
First PostedDec 24, 2014
Enrollment StartOct 1, 2015
Primary CompletionApr 1, 2020
Study CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.5 years ago
Interventions
DDD-CLSdevice
ODOdevice