NCT01490814 - FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation | Biotech Hunter

Enrollment

769

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

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.

Trial Locations (19)

1122

Semmelweis University of Medicine, Kardiovaskuläres Zentrum, Budapest

4031

Universitätsspital Basel, Elektrophysiologie/ Kardiologie, Basel

8011

Isala Klinieken loc. Weezenlanden Diagram Clinical Resarch, Zwolle

17475

Universitätsklinikum Greifswald Elektrophysiologie, Greifswald

20099

Asklepios Klinik St. Georg, Hamburg

20138

Cardiac Arrhythmia Research Centre Department of Cardiovascular Medicine Centro Cardiologico Monzino University of Milan, Milan

28040

Arrhythmia Unit Hospital Clinico San Carlos, Madrid

29010

Hospital Universitario Virgen de la Victoria, Department of Cardiology, Campus Teatinos sn, Málaga

31076

La Clinique Pasteur, 45 Avenue de Lombez, Toulouse

46014

Hospital Clinico Universtitario, Cardiology Department Arrhythmia Unit, Valencia

60431

Cardioangiologisches Centrum Bethanien - CCB, Frankfurt

69677

CHU Lyon, Départment de Rythmologie, Hospital Cardiologique Pradel, Lyon

78464

Herz-Zentrum-Bodensee Konstanz, Konstanz

79189

Herz-Zentrum Bad Krozingen, Bad Krozingen

92200

Centre Chirurgical Ambroise Paré, Neuilly-sur-Seine

94010

Hospital Henri Mondor CHU, Service de Cardiologie, Créteil

97616

Klinik für Kardiologie II mit interventioneller Elektrophysiologie, Bad Neustadt/Saale

515030

Na Homolce Hospital, Cardiology, Prague

08036

Hospital Clinic, University of Barcelona, Barcelona