Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions Identifier:
First received: August 29, 2011
Last updated: July 7, 2015
Last verified: July 2015
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.

Condition Intervention Phase
AtrioVentricular Nodal Reentrant Tachycardia
Supraventricular Tachycardia
Heart Disease
Device: Freezor Xtra Cryoablation Catheter
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)

Resource links provided by NLM:

Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • Number of Participants with Successful Procedures and No AtrioVentricular Nodal Reentrant Tachycardia Recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Subjects must meet both of the following conditions to be considered as a chronic effectiveness success:

    • The inability to induce more than one echo beat by the same pacing maneuvers that induced atrioventricular nodal reentrant tachycardia (AVNRT) before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the ablation procedure assessment (i.e. acute procedural success)
    • Lack of documented recurrence of clinical AVNRT during the 6 months follow-up period post the successful ablation procedure

  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    The primary safety endpoint is a success/failure variable calculated for each subject through 6 months follow-up. Subjects with at least one chronic safety event (serious adverse event determined to be ablation procedure or device related) during the cryoablation procedure and through the end of 6 months follow-up will be considered a primary safety failure.

Secondary Outcome Measures:
  • Number of Participants who had Acutely Successful Procedures and No Atrioventricular Nodal Reentrant Tachycardia Recurrence. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Demonstrate the chronic effectiveness (Lack of documented recurrence of clinical atrioventricular nodal reentrant tachycardia) of the Freezor® Xtra CryoAblation Catheter in the treatment of atrioventricular nodal reentrant tachycardia through 6 months in subjects who have achieved acute procedural success.

Estimated Enrollment: 850
Study Start Date: March 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cryoablation
Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.
Device: Freezor Xtra Cryoablation Catheter
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01426425

  Hide Study Locations
United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Pacific Heart Institute
Santa Monica, California, United States, 90404
Stanford Hospital and Clinics
Stanford, California, United States, 94305
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Orlando Heart Center
Orlando, Florida, United States, 32806
United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50314
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Park Nicollet Institute
St. Louis Park, Minnesota, United States, 55426
Healtheast St. Joseph's Hospital
St. Paul, Minnesota, United States, 55102
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States, 28203
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Miami Valley Cardiologists
Dayton, Ohio, United States, 45409
United States, Oregon
Sacred Heart Medical Center
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, United States, 17011
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Wellmont Cardiovascular Heart Institute
Kingsport, Tennessee, United States, 37660
United States, Texas
Baylor Heart and Vascular Hospital
Dallas, Texas, United States, 75226
St. Luke's Episcopal
Houston, Texas, United States, 77030
Baylor Research Institute
Plano, Texas, United States, 75093
United States, Virginia
Virginia Heart
Falls Church, Virginia, United States, 22042
United States, Wisconsin
Bellin Memorial
Green Bay, Wisconsin, United States, 54301
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5B9
Canada, Quebec
Hopital du Sacre Coeur de Montreal
Montreal, Quebec, Canada, H3A 1A1
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Prairie CardioVascular Research Network
Regina, Saskatchewan, Canada, S4P OW5
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Principal Investigator: Peter Wells, M.D. Baylor Univ Medical Ctr Dallas, TX.
  More Information

No publications provided

Responsible Party: Medtronic Atrial Fibrillation Solutions Identifier: NCT01426425     History of Changes
Other Study ID Numbers: ICY-AVNRT
Study First Received: August 29, 2011
Last Updated: July 7, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Medtronic Atrial Fibrillation Solutions:
Cardiac cryoablation
heart disease
AtrioVentricular Nodal Reentrant Tachycardia
Supraventricular tachycardia

Additional relevant MeSH terms:
Heart Diseases
Tachycardia, Atrioventricular Nodal Reentry
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Tachycardia, Reciprocating processed this record on November 27, 2015