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Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

NCT01426425 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2025-02-13

Study results available
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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.

Conditions

  • AtrioVentricular Nodal Reentrant Tachycardia
  • Supraventricular Tachycardia
  • Heart Disease

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Peter Wells, M.D. · Baylor Univ Medical Ctr Dallas, TX.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-09-30
Completion
2016-09-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01426425 on ClinicalTrials.gov