Comparative study of two types of pacing for the treatment of unexplained syncope (vasovagal syndrome): a multicentre, single-blinded, randomised controlled trial with a direct individual benefit

Croix Rousse University Hospital (France)0 个研究点目标入组 80 人开始时间: 2010年7月23日最近更新: 2021年1月11日

适应症

试验速览

•1. Adult patients (greater than or equal to 18 years), agreeing to take part in the study and having signed the informed consent form
•2. Patients having presented one or more episodes of syncope or pre-syncope unexplained by the usual screening tests: questionnaire, clinical examination, orthostatic hypotension investigation, biological tests, electrophysiological study (if necessary), echocardiogram (ECG), Holter, exercise test (optional), electroencephalogram (EEG) (optional), and brain scan (optional)
•3. Negative sino-carotid massage (SCM)
•4. Head-up tilt test conducted according to Appendix B protocol, whatever the result
•5. Positive adenosine-5'-triphospate (ATP) test, confirmed by double reading by principal investigator

•1. Syncope etiology revealed by usual screening testings
•2. Positive SCM
•3. Atrial or ventricular tachyarrhythmia
•4. Defibrillator implanted (DAI)
•5. Pacemaker previously implanted
•6. Patient on waiting list for or having had heart transplantation
•7. Sick sinus syndrome, brady-tachy syndrome
•8. Atrial fibrillation, paroxysmal or permanent first and second-degree atrio-ventricular block, trifascicular block
•9. Ongoing pregnancy. Women of childbearing age should be using reliable contraception.
•10. Acute systemic infection or other surgical contra-indication for pacemaker implantation
•11. Chronic obstructive bronchopneumopathy
•12. Asthma
•13. Diabetes

发起方

Croix Rousse University Hospital (France)