Skip to main content
OpenTrials
Completed

NCT Number: NCT01426425

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

AtrioVentricular Nodal Reentrant Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Disease Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Supraventricular Tachycardia Tachycardia Tachycardia, Atrioventricular Nodal Reentry Tachycardia, Reciprocating Tachycardia, Supraventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Alexandra Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Freezor Xtra Cryoablation Catheter

Device

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.

Primary outcomes

  1. Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.

    Time frame: 6 months

    Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success:

    • Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment.
    • Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.

  2. Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.

    Time frame: 6 Months

    Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.

Secondary outcomes

  1. Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.

    Time frame: 6 Months

    If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Ablation Solutions

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Aug 31, 2011
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.