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 |
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.
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
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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Advocate Christ Medical Center Advocate Health Care, named among the nation
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