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REVOLUTION (WFCC-133)
This study is currently recruiting participants.
Verified February 2012 by Biosense Webster, Inc.

First Received on May 12, 2011.   Last Updated on February 17, 2012   History of Changes
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)

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • the incidence of early onset primary adverse events [ Time Frame: 7 days of the mapping and ablation procedure ] [ Designated as safety issue: Yes ]
    The primary safety endpoint is the incidence of early onset primary adverse events within 7 days of the mapping and ablation procedure. Pulmonary vein stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure shall be deemed primary adverse event.

  • freedom from documented symptomatic atrial fibrillation [ Time Frame: Evaluated post 3 month blanking period, Day 91-361 ] [ Designated as safety issue: No ]
    The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation.


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)
Intervention Details:
    Device: Circular Mapping and Ablation catheter
    The Biosense Webster Pulmonary Vein Isolation System (Circular and Crescent Mapping and Ablation Catheters and the Multi-channel Radiofrequency Generator) is designed to facilitate electrophysiological mapping and transmit radiofrequency from multiple electrodes simultaneously.
    Device: Crescent Mapping and Ablation catheter
    The Biosense Webster Pulmonary Vein Isolation System (Circular and Crescent Mapping and Ablation Catheters and the Multi-channel Radiofrequency Generator) is designed to facilitate electrophysiological mapping and transmit radiofrequency from multiple electrodes simultaneously.
    Device: Multi-channel Radiofrequency Generator
    The Biosense Webster Pulmonary Vein Isolation System (Circular and Crescent Mapping and Ablation Catheters and the Multi-channel Radiofrequency Generator) is designed to facilitate electrophysiological mapping and transmit radiofrequency from multiple electrodes simultaneously.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with symptomatic PAF who have had at least one documented AF episode in the twelve (12) months prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter Monitor (HM), or telemetry strip.
  2. Failure of at least one antiarrhythmic drug for AF (class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers), as evidenced by recurrent symptomatic AF, or intolerable side effects.
  3. Age 18 years or older.
  4. Able and willing to comply with all pre-, post- and follow-up testing and requirements.
  5. Signed Patient Informed Consent Form.

Exclusion Criteria:

  1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  2. Patients with Persistent or Long-standing AF (AF episode lasting > 30 days in duration.
  3. Diagnosed atrial myxoma.
  4. Left atrial size > 5.5cm.
  5. Left Ventricular ejection fraction < 40%.
  6. Contraindication to CT/MRI procedures
  7. New York Heart Association Class III or IV.
  8. Previous ablation for enrolled arrhythmia (AF).
  9. Documented left atrial thrombus on imaging (eg transesophageal echocardiography or intracardiac echocardiography).
  10. Myocardial Infarction within the previous 60 days (2 months).
  11. Any valvular cardiac surgical procedure (ie, valve repair or replacement and presence of a prosthetic valve).
  12. Coronary artery bypass graft procedure with the last 180 days 6 months.
  13. Cardiac Surgery (i.e. ventriculotomy, atriotomy) within the past 60 days (2 months).
  14. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
  15. History of documented thromboembolic event within the past one (1) year.
  16. Significant pulmonary disease, (eg restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunctions of the lungs or respiratory system that produces chronic symptoms.
  17. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
  18. Active illness or active systemic infection or sepsis.
  19. Unstable angina.
  20. History of blood clotting or bleeding abnormalities.
  21. Contraindication to anticoagulation (ie Heparin or Warfarin).
  22. Life expectancy less than 365 days (12 months)
  23. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
  24. Women who are pregnant (as evidence by pregnancy test if subject is of child bearing potential) and/or breast feeding.
  25. Presence of a condition that precludes vascular access.
  26. Enrollment in an investigational study evaluating another device or drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353586

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            
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: Prof. Pierre Jais, MD Hop. Haut-Lévêque
  More Information

No publications provided

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012