Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)

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.

Pre-Electrophysiology Study Inclusion Criteria:

• Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor

Pre-Electrophysiology Study Exclusion Criteria:

• 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)