Status:
COMPLETED
Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
Lead Sponsor:
Medtronic Cardiac Ablation Solutions
Conditions:
AtrioVentricular Nodal Reentrant Tachycardia
Supraventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. ...
Eligibility Criteria
Inclusion
- Pre-Electrophysiology Study
- Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor
- Pre-Electrophysiology Study
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
572 Patients enrolled
Trial Details
Trial ID
NCT01426425
Start Date
May 1 2012
End Date
September 1 2016
Last Update
February 13 2025
Active Locations (34)
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1
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
2
Pacific Heart Institute
Santa Monica, California, United States, 90404
3
Stanford Hospital and Clinics
Stanford, California, United States, 94305
4
Baptist Hospital of Miami
Miami, Florida, United States, 33176