NCT Number: NCT02324920
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
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.
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Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
CHUS Sherbrooke, Sherbrooke, Canada
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients affected by clinical diagnosis of reflex syncope who meet all the following criteria:
- age >=40 years
- significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year.
- type 2B cardio-inhibitory response to TT (according to the VASIS classification).
- Alternative therapies have failed or were not feasible.
- exclusion of other possible competitive causes of syncope.
Exclusion criteria
- Any other indication to IPG, implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines
Any cardiac dysfunctions possibly leading to loss of consciousness:
- overt heart failure;
- ejection fraction (LVEF) <40% (Echo-assessed within 3-month prior to study participation);
- myocardial infarction;
- diagnosis of hypertrophic or dilated cardiomyopathy;
- clinically significant valvular disease;
- sinus bradycardia <50 bpm or sinoatrial block;
- Mobitz I second-degree atrioventricular block;
- Mobitz II second or third-degree atrioventricular block;
- bundle-branch block;
- rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;
- preexcited QRS complexes;
- prolonged QT interval;
- Brugada syndrome;
- arrhythmogenic right ventricular cardiomyopathy
- Symptomatic orthostatic hypotension diagnosed by standing BP measurement;
- Nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy).
- Symptomatic cardioinhibitory carotid sinus hypersensitivity.
Treatment and study plan
ODO
DevicePrimary outcomes
-
Patients With Recurrence of Syncopal Episode
Time frame: 24 months
Secondary outcomes
-
Patients With Recurrence of Pre-syncope or Syncope
Time frame: 24 months
Sponsors and collaborators
Lead sponsor
Biotronik SE & Co. KG
Industry
Registry information
Official study title
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.
Acronym: BIOSync CLS
Important dates
- Study start
- 2015
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Dec 24, 2014
- Registry last updated
- Nov 17, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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