Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
United States, Canada572 participantsStarted 2012-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (grea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
Timeframe: 6 months
2
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.