Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal<br>Supraventricular Tachycardias: a randomized controlled trial - COBRA-PATH

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 112 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。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:;* Referral for electrophysiology study because of pre-excitation on 12-lead surface ECG and/or documented (or suspected) symptomatic PSVT: palpitations associated with narrow-complex tachycardia (* 1 episode) documented by a 12-lead electrogram, Holter monitoring, transtelephonic event recorder, telemetry strip or implanted device (implantable loop recorder, pacemaker) within 12 months prior to referral to EPS; or frequent symptoms of palpitation (within 12 months prior to referral) associated with clinical signs highly suggestive of PSVT: 1, sudden onset and termination of rapid (and regular) palpitations usually accompanied with neck pulsation and/or dizziness, 2, termination with Valsalva maneuver or carotid sinus massage and 3, no evidence for an underlying structural heart disease.
•* Identification of AVNRT or WPW-AVRT (with manifest or concealed accessory pathway) during standard EP study.
•* Verbal consent to continue with ablation therapy after the diagnostic steps of the EPS identified the above mentioned arrhythmia mechanisms, and after the patient received sufficient information about the benefits and potential risks of the ablative treatment of the individual arrhythmia substrate.
•* Informed written consent to being included in the study.

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•1. evidence of structural heart disease and/or myocardial ischemia*
•2. pregnancy (and lack of exclusion of potential pregnancy)
•3. age below 18 years
•* as revealed by the medical history or diagnosed by either of the following modalities: echocardiography, (exercise) electrocardiogram, myocardial perfusion scan, coronary angiography, coronary CT-angiography or magnetic resonance imaging.

发起方