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Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

NCT03365700 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2018-02-23

No results posted yet for this study

Summary

A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation.

The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with short-term persistent AF.

Conditions

  • Persistent Atrial Fibrillation

Interventions

PROCEDURE

Radiofrequency Ablation

Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.

PROCEDURE

Cryoballoon ablation

Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. Additional substrate modification is allowed with the catheter type assigned at the index procedure.

Sponsors & Collaborators

  • Centro Cardiologico Monzino

    collaborator OTHER

  • Luigi Sacco University Hospital

    lead OTHER

Principal Investigators

  • Claudio Tondo, MD, PhD · Heart Rhythm Center at Monzino Cardiac Center, IRCCS.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-03-31
Completion
2020-08-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT03365700 on ClinicalTrials.gov