Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

Last updated: February 11, 2025
Sponsor: Medtronic Cardiac Ablation Solutions
Overall Status: Completed

Phase

3

Condition

Cardiovascular Disease

Arrhythmia

Cardiac Disease

Treatment

Freezor Xtra Cryoablation Catheter

Clinical Study ID

NCT01426425
ICY-AVNRT
  • Ages > 18
  • All Genders

Study 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

Inclusion

Pre-Electrophysiology Study Inclusion Criteria:

  • Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentranttachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor

Exclusion

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 thepast 90 days

  • Implantable cardiac rhythm device

  • Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or thirddegree) 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 (forexample, intracardiac mural thrombus)

  • Participating in a concurrent clinical study that may confound the results of thisstudy

Post-Electrophysiology Study Inclusion Criteria:

  • Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that isclassified as AVNRT.

Post-Electrophysiology Study Exclusion Criteria:

  • Presence of a second inducible arrhythmia that could be confused with AVNRT duringfollow-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 atrioventricularconduction system.

  • Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)

Study Design

Total Participants: 572
Treatment Group(s): 1
Primary Treatment: Freezor Xtra Cryoablation Catheter
Phase: 3
Study Start date:
May 01, 2012
Estimated Completion Date:
September 30, 2016

Connect with a study center

  • Royal Alexandra Hospital

    Edmonton, Alberta T5H 3V9
    Canada

    Site Not Available

  • Victoria Cardiac Arrhythmia Trials, Inc.

    Victoria, British Columbia V8R 4R2
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5B9
    Canada

    Site Not Available

  • Hopital du Sacre Coeur de Montreal

    Montreal, Quebec H3A 1A1
    Canada

    Site Not Available

  • McGill University Health Centre

    Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Prairie CardioVascular Research Network

    Regina, Saskatchewan S4P OW5
    Canada

    Site Not Available

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Cardiology Associates of Northeast Arkansas

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Santa Barbara Cottage Hospital

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Pacific Heart Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Stanford Hospital and Clinics

    Stanford, California 94305
    United States

    Site Not Available

  • Baptist Hospital of Miami

    Miami, Florida 33176
    United States

    Site Not Available

  • Orlando Regional Medical Center

    Orlando, Florida 32806
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Advocate Christ Medical Center

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Iowa Heart Center

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • University of Michigan Medical Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Park Nicollet Institute

    Saint Louis Park, Minnesota 55426
    United States

    Site Not Available

  • Healtheast St. Joseph's Hospital

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Park Nicollet Institute

    St. Louis Park, Minnesota 55426
    United States

    Site Not Available

  • Healtheast St. Joseph's Hospital

    St. Paul, Minnesota 55102
    United States

    Site Not Available

  • Southside Hospital

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Sanger Heart and Vascular Institute

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Miami Valley Cardiologists

    Dayton, Ohio 45409
    United States

    Site Not Available

  • Sacred Heart Medical Center

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Capital Cardiovascular Associates

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Reading Hospital and Medical Center

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania 18711
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Wellmont Cardiovascular Heart Institute

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Baylor Heart and Vascular Hospital

    Dallas, Texas 75226
    United States

    Site Not Available

  • St. Luke's Episcopal

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor Research Institute

    Plano, Texas 75093
    United States

    Site Not Available

  • Virginia Heart

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Bellin Memorial

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

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