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FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation

NCT01490814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 769

Last updated 2026-04-13

Study results available
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Summary

Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.

Conditions

  • Symptomatic Paroxysmal Atrial Fibrillation (PAF)

Interventions

PROCEDURE

Electrical isolation of the pulmonary veins

Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

PROCEDURE

Electrical isolation of pulmonary veins

Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Karl-Heinz Kuck, Prof. Dr. · Asklepios Klinikum St. Georg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Spain
  • Switzerland

Study Locations

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Entities

Companies

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 NCT01490814 on ClinicalTrials.gov