REVOLUTION (WFCC-133)
This study is ongoing, but not recruiting participants.
Sponsor:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01353586
First received: May 12, 2011
Last updated: April 17, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
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: | 220 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 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:
- 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.
- 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.
- Age 18 years or older.
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
- Signed Patient Informed Consent Form.
Exclusion Criteria:
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Patients with Persistent or Long-standing AF (AF episode lasting > 30 days in duration.
- Diagnosed atrial myxoma.
- Left atrial size > 5.5cm.
- Left Ventricular ejection fraction < 40%.
- Contraindication to CT/MRI procedures
- New York Heart Association Class III or IV.
- Previous ablation for enrolled arrhythmia (AF).
- Documented left atrial thrombus on imaging (eg transesophageal echocardiography or intracardiac echocardiography).
- Myocardial Infarction within the previous 60 days (2 months).
- Any valvular cardiac surgical procedure (ie, valve repair or replacement and presence of a prosthetic valve).
- Coronary artery bypass graft procedure with the last 180 days 6 months.
- Cardiac Surgery (i.e. ventriculotomy, atriotomy) within the past 60 days (2 months).
- Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
- History of documented thromboembolic event within the past one (1) year.
- 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.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- Active illness or active systemic infection or sepsis.
- Unstable angina.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation (ie Heparin or Warfarin).
- Life expectancy less than 365 days (12 months)
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
- Women who are pregnant (as evidence by pregnancy test if subject is of child bearing potential) and/or breast feeding.
- Presence of a condition that precludes vascular access.
- 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 | |
| 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: | April 17, 2013 |
| 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 May 16, 2013