Benefit of dual-chamber pacing with Closed Loop Stimulation (CLS) in tilt-induced cardio-inhibitory reflex syncope. A randomized double-blind parallel trial. - BIOSync CLS study

Biotronik0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•*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 TTT (according
•to the VASIS classification).
•*alternative therapies have failed or are not feasible.
•*exclusion of other possible competitive causes of syncope.

•*Any other indication to IPG (pacemaker), 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;...
•*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.

发起方