Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Medtronic Atrial Fibrillation Solutions

Intervention(s):

  • Device: Freezor Xtra Cryoablation Catheter

Phase:

Phase 3

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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Gerri O'Riordan
650-725-5597
Not Recruiting