Overview

This trial is active, not recruiting.

Conditions atrioventricular nodal reentrant tachycardia, supraventricular tachycardia, heart disease
Treatment freezor xtra cryoablation catheter
Phase phase 3
Sponsor Medtronic Atrial Fibrillation Solutions
Start date March 2012
End date September 2015
Trial size 572 participants
Trial identifier NCT01426425, ICY-AVNRT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.
freezor xtra cryoablation catheter
Freezor® Xtra Cardiac CryoAblation applied for cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia using an endocardial approach.

Primary Outcomes

Measure
Number of Participants with Successful Procedures and No AtrioVentricular Nodal Reentrant Tachycardia Recurrence
time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety
time frame: 6 Months

Secondary Outcomes

Measure
Number of Participants who had Acutely Successful Procedures and No Atrioventricular Nodal Reentrant Tachycardia Recurrence.
time frame: 6 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
Principal investigator Peter Wells, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Medtronic Atrial Fibrillation Solutions.