Clinical trial NCT01353586: REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-13
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The Incidence of Early Onset Primary Adverse Events
timeFrame: 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)
measure: Incidence of Freedom From Documented Symptomatic Atrial Fibrillation
timeFrame: Evaluated from Day 91 to Day 240
Secondary outcomes:
measure: Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months
timeFrame: 12 months post study procedure
measure: Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation
timeFrame: Three months after index ablation
measure: Incidence of Completion of Ablation Procedure
timeFrame: From 7 days to 12 months post study procedure
measure: Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure
timeFrame: 6 and12 months post study procedure
measure: Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation
timeFrame: 48 hours post-ablation
measure: Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation
timeFrame: 48 hours post-ablation
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ St Jan, Cardiologie
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
city: Varde
country: Denmark
facility: HCV HjerteCenter Varde
city: Bordeaux
country: France
facility: HHL Hop. Haut-Lévêque
city: Nancy
country: France
facility: HDB CHU de Nancy
city: Leipzig
country: Germany
facility: HLG Herzzentrum Leipzig GmbH
city: Acquaviva delle Fonti
country: Italy
facility: OFM Ospedale Generale Regionale
city: Milan
country: Italy
facility: CCM Centro Cardiologico Monzino
Study officials:
affiliation: Hop. Haut-Lévêque
name: Prof. Pierre Jais, MD
role: PRINCIPAL_INVESTIGATOR
References: