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

NCT01353586 | Completed Phase 2 Results DMC FDA Device

• 1 other identifier: WFCC-133
• Study Type: interventional
• Target: 186
• Locations: 6 countries
• Sites: 8

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).

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• The Incidence of Early Onset Primary Adverse Events

  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.

  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)

• Incidence of Freedom From Documented Symptomatic Atrial Fibrillation

  The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation.

  Evaluated from Day 91 to Day 240

Secondary Outcomes (6)

• Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months

  12 months post study procedure

• Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation

  Three months after index ablation

• Incidence of Completion of Ablation Procedure

  From 7 days to 12 months post study procedure

• Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure

  6 and12 months post study procedure

• Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation

  48 hours post-ablation

Study Arms (1)

nMARQ™ System

EXPERIMENTAL

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

Interventions

nMARQ™ System DEVICE

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

Also known as: 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)

nMARQ™ System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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 Computed Axial Tomography/Magnetic Resonance Imaging (CT/MRI) procedures
• New York Heart Association Class III or IV.
• Previous ablation for enrolled arrhythmia (AF).
• Documented left atrial thrombus on imaging (example: transesophageal echocardiography or intracardiac echocardiography).
• Myocardial Infarction within the previous 60 days (2 months).
• Any valvular cardiac surgical procedure (that is, valve repair or replacement and presence of a prosthetic valve).
• Coronary artery bypass graft procedure with the last 180 days 6 months.
• Cardiac Surgery (that is, 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (8)

AZ St Jan, Cardiologie

Bruges, Belgium

Location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, Czechia

Location

HCV HjerteCenter Varde

Varde, DK-6800, Denmark

Location

HHL Hop. Haut-Lévêque

Bordeaux, France

Location

HDB CHU de Nancy

Nancy, France

Location

HLG Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

OFM Ospedale Generale Regionale

Acquaviva delle Fonti, 70021, Italy

Location

CCM Centro Cardiologico Monzino

Milan, 20138, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radionuclide Generators

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiation Equipment and Supplies; Equipment and Supplies

Results Point of Contact

• Title: Kendra McInnis, Manager, Clinical Operations
• Organization: Biosense Webster, Inc

kmcinnis@its.jnj.com

909-839-7284

Study Officials

• Prof. Pierre Jais, MD

  Hop. Haut-Lévêque

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 13, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 6, 2017
• Results First Posted: February 2, 2016

Record last verified: 2017-05

Locations

DK (1); BE (1); FR (2); IT (2); DE (1); CZ (1)