REVOLUTION (WFCC-133)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01353586
First received: May 12, 2011
Last updated: May 14, 2014
Last verified: May 2014
  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.


Enrollment: 186
Study Start Date: March 2011
Estimated Study Completion Date: May 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Circular and Crescent Mapping and Ablation Catheter 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353586

Locations
Belgium
AZ St Jan, Cardiologie
Brugge, Belgium
Czech Republic
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czech Republic
Denmark
HCV HjerteCenter Varde
Varde, Denmark, DK-6800
France
HHL Hop. Haut-Lévêque
Bordeaux, France
HDB CHU de Nancy
Nancy, France
Germany
HLG Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Italy
OFM Ospedale Generale Regionale
Acquaviva delle Fonti, Italy, 70021
CCM Centro Cardiologico Monzino
Milan, Italy, 20138
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: May 14, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 28, 2014