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| Sponsor: | Biosense Webster, Inc. |
|---|---|
| Information provided by (Responsible Party): | Biosense Webster, Inc. |
| ClinicalTrials.gov Identifier: | NCT01353586 |
Purpose
The purpose of this study is to assess the safety and effectiveness of the Circular and Crescent Mapping and Ablation catheters and the workflow of the Multi-Electrode Irrigated Pulmonary Vein Isolation System when used for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
| Condition | Intervention | Phase |
|---|---|---|
|
Paroxysmal Atrial Fibrillation |
Device: Circular Mapping and Ablation catheter Device: Crescent Mapping and Ablation catheter Device: Multi-channel Radiofrequency Generator |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | REVOLUTION (WFCC-133): Clinical Workflow Study for the Evaluation of the Multi-Electrode Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) |
| Estimated Enrollment: | 145 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Belgium | |
| AZ St Jan, Cardiologie | Recruiting |
| Brugge, Belgium | |
| Contact: Dianne Van Kats +32(0)50 45 28 96 | |
| Principal Investigator: Mattias Duytschaever, MD | |
| Czech Republic | |
| Institute for Clinical and Experimental Medicine (IKEM) | Recruiting |
| Prague, Czech Republic | |
| Contact: Ivana (Nemcova) Kamenářová +420 739 686 618 | |
| Principal Investigator: Prof. Josef Kautzner, MD | |
| Denmark | |
| HCV HjerteCenter Varde | Not yet recruiting |
| Varde, Denmark, DK-6800 | |
| Contact: NA NA | |
| Principal Investigator: Peter Hansen, MD | |
| France | |
| CPT Clinique Pasteur Toulouse | Not yet recruiting |
| Paris, Toulouse, France, 31300 | |
| Contact: NA | |
| Principal Investigator: Jean-Paul Albenque, MD | |
| HHL Hop. Haut-Lévêque | Recruiting |
| Bordeaux, France | |
| Contact: Helene Videau +33(0)5 56 79 56 79 | |
| Principal Investigator: Prof. Pierre Jais, MD | |
| HDB CHU de Nancy | Recruiting |
| Nancy, France | |
| Contact: Edith Marchal +33 3 83 15 38 81 | |
| Principal Investigator: Prof. Christian De Chillou, MD | |
| Germany | |
| HLG Herzzentrum Leipzig GmbH | Not yet recruiting |
| Leipzig, Germany, 04289 | |
| Contact: NA | |
| Principal Investigator: Gerhard Hindricks, MD | |
| Italy | |
| OFM Ospedale Generale Regionale | Recruiting |
| Acquaviva delle Fonti, Italy, 70021 | |
| Contact: Mario Petruzzi blur@libero.it | |
| Principal Investigator: Massimo Grimaldi, MD | |
| CCM Centro Cardiologico Monzino | Recruiting |
| Milan, Italy, 20138 | |
| Contact: Vittoria Marino vittoria.marino@ccfm.it | |
| Principal Investigator: Claudio Tondo, MD | |
| United Kingdom | |
| RBH Royal Brompton and Harefield Hospital | Not yet recruiting |
| London, United Kingdom, SW3 6NP | |
| Contact: NA | |
| Principal Investigator: Sabine Ernst, MD | |
| Principal Investigator: | Prof. Pierre Jais, MD | Hop. Haut-Lévêque |
More Information
| Responsible Party: | Biosense Webster, Inc. |
| ClinicalTrials.gov Identifier: | NCT01353586 History of Changes |
| Other Study ID Numbers: | WFCC-133 |
| Study First Received: | May 12, 2011 |
| Last Updated: | February 17, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes France: Afssaps - French Health Products Safety Agency |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |