REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation (REVOLUTION)
|ClinicalTrials.gov Identifier: NCT01353586|
Recruitment Status : Completed
First Posted : May 13, 2011
Results First Posted : February 2, 2016
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Device: nMARQ™ System||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||September 1, 2013|
|Study Completion Date :||September 1, 2013|
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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353586
|AZ St Jan, Cardiologie|
|Institute for Clinical and Experimental Medicine (IKEM)|
|HCV HjerteCenter Varde|
|Varde, Denmark, DK-6800|
|HHL Hop. Haut-Lévêque|
|HDB CHU de Nancy|
|HLG Herzzentrum Leipzig GmbH|
|Leipzig, Germany, 04289|
|OFM Ospedale Generale Regionale|
|Acquaviva delle Fonti, Italy, 70021|
|CCM Centro Cardiologico Monzino|
|Milan, Italy, 20138|
|Principal Investigator:||Prof. Pierre Jais, MD||Hop. Haut-Lévêque|