Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
Trial ID or NCT#
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to demonstrate the safety and effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT) using an endocardial approach.
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
- - Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor Pre-Electrophysiology Study
- - History of sustained (≥30 seconds) of ventricular tachycardia - Atrial tachycardia or other arrhythmia that could be confused with AVNRT - Reversible cause of SVT - History of previous AVNRT ablation - Therapy with amiodarone within last 90 days - Unstable angina/myocardial infarction/open heart surgery in past 60 days - New York Heart Association (NYHA) Classification III or IV currently or within the past 90 days - Implantable cardiac rhythm device - Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or third degree) or left bundle branch block - Stroke or transient ischemic attack within the past 180 days - Life expectancy less than 12 months - Female known to be pregnant - Unable/unwilling to give informed consent - Unable/unwilling to comply with follow-up visits and study requirements - Less than 18 years of age - Active systemic infection - Cryoglobulinemia - Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus) - Participating in a concurrent clinical study that may confound the results of this study Post-Electrophysiology Study Inclusion Criteria: - Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as AVNRT. Post-Electrophysiology Study Exclusion Criteria: - Presence of a second inducible arrhythmia that could be confused with AVNRT during follow-up or will likely result in ablation within the next 6 months - Presence of inducible sustained ventricular tachycardia or fibrillation - Presence of an accessory pathway - Presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system. - Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)
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