Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
Condition: AtrioVentricular Nodal Reentrant Tachycardia; Supraventricular Tachycardia; Heart Disease
MeSH terms: Heart Diseases; Tachycardia; Tachycardia, Supraventricular; Tachycardia, Atrioventricular Nodal Reentry
Intervention: Freezor Xtra Cryoablation Catheter
Intervention description: Freezor® Xtra Cardiac CryoAblation applied for cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia using an endocardial approach.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 572.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac cryoablation; AVNRT; heart disease; tachycardia; AtrioVentricular Nodal Reentrant Tachycardia; Supraventricular tachycardia; SVT

Summary:

      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.
    

Eligibility 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)