Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
NCT ID: NCT01426425
Last Updated: 2025-02-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
572 participants
INTERVENTIONAL
2012-05-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cryoablation
Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.
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.
Interventions
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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.
Eligibility Criteria
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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.
Exclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Ablation Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Wells, M.D.
Role: PRINCIPAL_INVESTIGATOR
Baylor Univ Medical Ctr Dallas, TX.
Locations
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Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Pacific Heart Institute
Santa Monica, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
Baptist Hospital of Miami
Miami, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Iowa Heart Center
Des Moines, Iowa, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, United States
Healtheast St. Joseph's Hospital
Saint Paul, Minnesota, United States
Southside Hospital
Bay Shore, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Miami Valley Cardiologists
Dayton, Ohio, United States
Sacred Heart Medical Center
Springfield, Oregon, United States
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Wellmont Cardiovascular Heart Institute
Kingsport, Tennessee, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
St. Luke's Episcopal
Houston, Texas, United States
Baylor Research Institute
Plano, Texas, United States
Virginia Heart
Falls Church, Virginia, United States
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Hopital du Sacre Coeur de Montreal
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Prairie CardioVascular Research Network
Regina, Saskatchewan, Canada
Countries
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References
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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.
Other Identifiers
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ICY-AVNRT
Identifier Type: -
Identifier Source: org_study_id
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