CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 572 enrolled
Drug / intervention
Freezor Xtra Cryoablation Catheterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01426425
NCT01426425Phase 3Completed
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ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)

Medtronic Cardiac Ablation Solutions·interventional·Posted Aug 31, 2011·Updated Feb 13, 2025

In Brief

A Phase 3 clinical trial evaluating Freezor Xtra Cryoablation Catheter for AtrioVentricular Nodal Reentrant Tachycardia and 2 related conditions. Completed, enrolled 572 participants across 34 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia, Heart Disease
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 31, 2011
Enrollment StartMay 1, 2012
Primary CompletionSep 1, 2015
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.8 years ago

Interventions

Freezor Xtra Cryoablation Catheterdevice

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.