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

May 12, 2011
May 14, 2014
March 2011
September 2013   (final data collection date for primary outcome measure)
  • 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.
  • 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 AE.
  • freedom from documented symptomatic AF [ 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 AF based on electrocardiographic data through 8 months post ablation.
Complete list of historical versions of study NCT01353586 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
REVOLUTION (WFCC-133)
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
  • 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.
Experimental: Circular and Crescent Mapping and Ablation Catheter
Interventions:
  • Device: Circular Mapping and Ablation catheter
  • Device: Crescent Mapping and Ablation catheter
  • Device: Multi-channel Radiofrequency Generator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
186
May 2014
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Italy,   Denmark,   France,   Germany,   Czech Republic
 
NCT01353586
WFCC-133
Not Provided
Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
Principal Investigator: Prof. Pierre Jais, MD Hop. Haut-Lévêque
Biosense Webster, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP