Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/21/2018
Start Date:May 2012
End Date:September 2016

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ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)

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.


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)
We found this trial at
27
sites
Atlanta, Georgia 30309
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1414 Kuhl Avenue
Orlando, Florida 32806
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Orlando, FL
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Bay Shore, New York 11706
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Camp Hill, Pennsylvania 17011
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Camp Hill, PA
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Charlotte, North Carolina 28203
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Charlotte, NC
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Dallas, TX
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Dayton, Ohio 45409
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Dayton, OH
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Des Moines, Iowa 50314
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Des Moines, IA
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Edmonton, Alberta
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Edmonton,
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Falls Church, Virginia 22042
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Falls Church, VA
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Houston, Texas 77030
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Kingsport, Tennessee 37660
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Kingsport, TN
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8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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Miami, FL
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Phoenix, Arizona 85006
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Plano, Texas 75093
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Saint Louis Park, Minnesota 55416
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Saint Paul, Minnesota 55102
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Santa Monica, California 90404
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Springfield, Oregon 97477
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Stanford, California 94305
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Wilkes-Barre, Pennsylvania 18711
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Wilkes-Barre, PA
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