REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation (REVOLUTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01353586
Recruitment Status : Completed
First Posted : May 13, 2011
Results First Posted : February 2, 2016
Last Update Posted : June 6, 2017
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: nMARQ™ System Phase 2

Detailed Description:
The study will include a Workflow Phase to verify consistent workflow of all study device components and evaluate acute safety. Upon meeting the defined criteria, the Workflow Phase will be closed and further enrollment will be toward the Main Study Phase which includes the roll-in (the first 3 subjects enrolled at each site following the closure of the Workflow Phase) and Subpopulation Neurological Assessments (SNA) substudy subjects. SNA assessment is a prospective, non-randomized, controlled, acute assessment of two ablation devices to determine if intracerebral microemboli are generated during or immediately after radiofrequency ablation therapy for PAF. SNA subjects will remain and complete the Main Study Phase. However, SNA-control subjects will not be considered part of the Main Study Phase. All subjects, including the subjects enrolled under the Workflow Phase will be included in the Safety Cohort (evaluated for Primary Safety endpoint and all Secondary Safety endpoints).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : March 1, 2011
Actual Primary Completion Date : September 1, 2013
Actual Study Completion Date : September 1, 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: nMARQ™ System
The nMARQ™ System (Circular and Crescent Mapping and Ablation Catheters as well as the Multi-Channel Radiofrequency Generator) as part of the Multi-Electrode Irrigated Pulmonary Vein (PV) Isolation System will serve as a treatment method for subjects undergoing radiofrequency catheter ablation for drug refractory, symptomatic Paroxysmal Atrial Fibrillation (PAF). The study later included a Subpopulation Neurological Assessments (SNA) substudy which is a prospective, non-randomized, controlled, acute assessment to compare subjects treated with the nMARQ™ System against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.
Device: nMARQ™ System
The nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon.
Other Names:
  • nMARQ™ Circular and Crescent Mapping and Ablation Catheters
  • Circular/Crescent Ablation Catheters
  • nMARQ™ Catheters
  • Circular/Crescent Irrigated catheters
  • Multi-Channel Radiofrequency (RF) Generator
  • nMARQ™ Generator
  • nMARQ™ Multi-Electrode Irrigated Pulmonary Vein (PV)

Primary Outcome Measures :
  1. The Incidence of Early Onset Primary Adverse Events [ Time Frame: Any of above events occurring within 7 days post-procedure (also including the incidence of pulmonary vein stenosis and atrio-esophageal fistula occurring > 7 days and up to one year post-procedure) ]
    The primary safety endpoint is the incidence of early onset primary adverse events within 7 days of the mapping and ablation procedure. Primary adverse events include pericardial effusion requiring intervention, atrial perforation, pericarditis requiring intervention, cardiac tamponade, pneumothorax, death, pulmonary edema, diaphragmatic paralysis, heart block, stroke / cerebrovascular accident (CVA), hospitalization (initial and prolonged), thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), and vascular access complications. In addition, pulmonary vein stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure are deemed primary adverse event.

  2. Incidence of Freedom From Documented Symptomatic Atrial Fibrillation [ Time Frame: Evaluated from Day 91 to Day 240 ]
    The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation.

Secondary Outcome Measures :
  1. Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months [ Time Frame: 12 months post study procedure ]
    This secondary safety endpoint includes non-primary serious adverse events within 7 days post-procedure and serious adverse events from 7 days to 12 months post-procedure.

  2. Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation [ Time Frame: Three months after index ablation ]
    Incidence of narrowing of PV and stenosis at 3 months post ablation, for subjects with available CT/MRA scans at 3 months. PV Stenosis is defined as 70% or more PV diameter reduction.

  3. Incidence of Completion of Ablation Procedure [ Time Frame: From 7 days to 12 months post study procedure ]
    This secondary outcome describes the acute effectiveness, which is defined as pulmonary vein isolation (PVI) documented by confirmed entrance block (with or without the use of a focal catheter).

  4. Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure [ Time Frame: 6 and12 months post study procedure ]
    This endpoint is defined as the absence of documented symptomatic PAF recurrence through 6 months and 12 months post index ablation procedure.

  5. Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation [ Time Frame: 48 hours post-ablation ]
    Evaluation of post-ablation generation incidence of asymptomatic cerebral microembolic lesions post ablation, as documented by MRI. All microembolic lesions reported in this study are asymptomatic.

  6. Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation [ Time Frame: 48 hours post-ablation ]
    All SNA subjects were to be evaluated by expert neurologists for existing neurological deficits prior to ablation procedure. After procedure, those subjects were also to be assessed for new neurological deficits.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with symptomatic Paroxysmal Atrial Fibrillation (PAF) who have had at least one documented Atrial Fibrillation (AF) episode in the twelve (12) months prior to enrollment. Documentation may include electrocardiogram (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 Atrioventricular (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 Computed Axial Tomography/Magnetic Resonance Imaging (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 (example: transesophageal echocardiography or intracardiac echocardiography).
  10. Myocardial Infarction within the previous 60 days (2 months).
  11. Any valvular cardiac surgical procedure (that is, 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 (that is, 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, (example: 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 (that is, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01353586

AZ St Jan, Cardiologie
Brugge, Belgium
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
HCV HjerteCenter Varde
Varde, Denmark, DK-6800
HHL Hop. Haut-Lévêque
Bordeaux, France
HDB CHU de Nancy
Nancy, France
HLG Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
OFM Ospedale Generale Regionale
Acquaviva delle Fonti, Italy, 70021
CCM Centro Cardiologico Monzino
Milan, Italy, 20138
Sponsors and Collaborators
Biosense Webster, Inc.
Principal Investigator: Prof. Pierre Jais, MD Hop. Haut-Lévêque

Responsible Party: Biosense Webster, Inc. Identifier: NCT01353586     History of Changes
Other Study ID Numbers: WFCC-133
First Posted: May 13, 2011    Key Record Dates
Results First Posted: February 2, 2016
Last Update Posted: June 6, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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