Phase
Condition
Cardiovascular Disease
Arrhythmia
Cardiac Disease
Treatment
Freezor Xtra Cryoablation Catheter
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Royal Alexandra Hospital
Edmonton, Alberta T5H 3V9
CanadaSite Not Available
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia V8R 4R2
CanadaSite Not Available
London Health Sciences Centre
London, Ontario N6A 5B9
CanadaSite Not Available
Hopital du Sacre Coeur de Montreal
Montreal, Quebec H3A 1A1
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Montreal Heart Institute
Montreal, Quebec H1T 1C8
CanadaSite Not Available
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Prairie CardioVascular Research Network
Regina, Saskatchewan S4P OW5
CanadaSite Not Available
Banner Good Samaritan Medical Center
Phoenix, Arizona 85006
United StatesSite Not Available
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas 72401
United StatesSite Not Available
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
United StatesSite Not Available
Pacific Heart Institute
Santa Monica, California 90404
United StatesSite Not Available
Stanford Hospital and Clinics
Stanford, California 94305
United StatesSite Not Available
Baptist Hospital of Miami
Miami, Florida 33176
United StatesSite Not Available
Orlando Regional Medical Center
Orlando, Florida 32806
United StatesSite Not Available
Piedmont Heart Institute
Atlanta, Georgia 30309
United StatesSite Not Available
Advocate Christ Medical Center
Oak Lawn, Illinois 60453
United StatesSite Not Available
Iowa Heart Center
Des Moines, Iowa 50314
United StatesSite Not Available
University of Michigan Medical Center
Ann Arbor, Michigan 48109
United StatesSite Not Available
Park Nicollet Institute
Saint Louis Park, Minnesota 55426
United StatesSite Not Available
Healtheast St. Joseph's Hospital
Saint Paul, Minnesota 55102
United StatesSite Not Available
Park Nicollet Institute
St. Louis Park, Minnesota 55426
United StatesSite Not Available
Healtheast St. Joseph's Hospital
St. Paul, Minnesota 55102
United StatesSite Not Available
Southside Hospital
Bay Shore, New York 11706
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
Sanger Heart and Vascular Institute
Charlotte, North Carolina 28203
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Miami Valley Cardiologists
Dayton, Ohio 45409
United StatesSite Not Available
Sacred Heart Medical Center
Springfield, Oregon 97477
United StatesSite Not Available
Capital Cardiovascular Associates
Camp Hill, Pennsylvania 17011
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822
United StatesSite Not Available
Reading Hospital and Medical Center
West Reading, Pennsylvania 19611
United StatesSite Not Available
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania 18711
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Wellmont Cardiovascular Heart Institute
Kingsport, Tennessee 37660
United StatesSite Not Available
Baylor Heart and Vascular Hospital
Dallas, Texas 75226
United StatesSite Not Available
St. Luke's Episcopal
Houston, Texas 77030
United StatesSite Not Available
Baylor Research Institute
Plano, Texas 75093
United StatesSite Not Available
Virginia Heart
Falls Church, Virginia 22042
United StatesSite Not Available
Bellin Memorial
Green Bay, Wisconsin 54301
United StatesSite Not Available


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