Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
1 other identifier
interventional
572
2 countries
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2012
Typical duration for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 31, 2011
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
March 31, 2017
CompletedFebruary 13, 2025
February 1, 2025
3.3 years
August 29, 2011
September 22, 2016
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
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.
6 months
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
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.
6 Months
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.
6 Months
Study Arms (1)
Cryoablation
EXPERIMENTALSubjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426, United States
Healtheast St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
Southside Hospital
Bay Shore, New York, 11706, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28203, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Miami Valley Cardiologists
Dayton, Ohio, 45409, United States
Sacred Heart Medical Center
Springfield, Oregon, 97477, United States
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, 17011, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Wellmont Cardiovascular Heart Institute
Kingsport, Tennessee, 37660, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
St. Luke's Episcopal
Houston, Texas, 77030, United States
Baylor Research Institute
Plano, Texas, 75093, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, V8R 4R2, Canada
London Health Sciences Centre
London, Ontario, N6A 5B9, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Hopital du Sacre Coeur de Montreal
Montreal, Quebec, H3A 1A1, Canada
McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Prairie CardioVascular Research Network
Regina, Saskatchewan, S4P OW5, Canada
Related Publications (1)
Wells P, Dubuc M, Klein GJ, Dan D, Roux JF, Lockwood E, Sturmer M, Dunbar D, Novak P, Rao A, Peterson BJ, Kueffer F, Ellenbogen KA; ICY-AVNRT Investigators. Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, North American study (ICY-AVNRT STUDY). J Cardiovasc Electrophysiol. 2018 Jan;29(1):167-176. doi: 10.1111/jce.13367. Epub 2017 Nov 10.
PMID: 29044787DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jo Krueger, Senior Clinical Research Specialist
- Organization
- Medtronic
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Wells, M.D.
Baylor Univ Medical Ctr Dallas, TX.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2011
First Posted
August 31, 2011
Study Start
May 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2016
Last Updated
February 13, 2025
Results First Posted
March 31, 2017
Record last verified: 2025-02