Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

Medtronic Cardiac Ablation Solutions

Status and phase

Completed

Phase 3

Conditions

AtrioVentricular Nodal Reentrant Tachycardia

Supraventricular Tachycardia

Heart Disease

Treatments

Device: Freezor Xtra Cryoablation Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT01426425

ICY-AVNRT

Details and patient eligibility

About

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.

Enrollment

572 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)