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Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
Not Recruiting
Trial ID: NCT01426425
Purpose
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.
Official Title
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
Eligibility
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)
Intervention(s):
device: Freezor Xtra Cryoablation Catheter
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Gerri O'Riordan
650-725-5597