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

NCT ID: NCT01353586

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-01
• Study Completion Date: 2013-09-01

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).

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

nMARQ™ System

Intervention Type: DEVICE

The nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon.

Interventions

nMARQ™ System

The nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon.

Intervention Type: DEVICE

Other Intervention 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)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Pierre Jais, MD

Role: PRINCIPAL_INVESTIGATOR

Hop. Haut-Lévêque

Locations

AZ St Jan, Cardiologie

Bruges, , Belgium

Institute for Clinical and Experimental Medicine (IKEM)

Prague, , Czechia

HCV HjerteCenter Varde

Varde, , Denmark

HHL Hop. Haut-Lévêque

Bordeaux, , France

HDB CHU de Nancy

Nancy, , France

HLG Herzzentrum Leipzig GmbH

Leipzig, , Germany

OFM Ospedale Generale Regionale

Acquaviva delle Fonti, , Italy

CCM Centro Cardiologico Monzino

Milan, , Italy

Countries

Belgium; Czechia; Denmark; France; Germany; Italy

Other Identifiers

WFCC-133

Identifier Type: -

Identifier Source: org_study_id