Back to resultsREVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation (REVOLUTION)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nMARQ™ System
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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.
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 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.
- 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.
- 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 (that is, 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.
Sites / Locations
- AZ St Jan, Cardiologie
- Institute for Clinical and Experimental Medicine (IKEM)
- HCV HjerteCenter Varde
- HHL Hop. Haut-Lévêque
- HDB CHU de Nancy
- HLG Herzzentrum Leipzig GmbH
- OFM Ospedale Generale Regionale
- CCM Centro Cardiologico Monzino
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nMARQ™ System
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01353586
Brief Title
REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation
Acronym
REVOLUTION
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2011 (Actual)
Primary Completion Date
September 1, 2013 (Actual)
Study Completion Date
September 1, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nMARQ™ System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
nMARQ™ System
Other Intervention Name(s)
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)
Intervention Description
The nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon.
Primary Outcome Measure Information:
Title
The Incidence of Early Onset Primary Adverse Events
Description
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.
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)
Title
Incidence of Freedom From Documented Symptomatic Atrial Fibrillation
Description
The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation.
Time Frame
Evaluated from Day 91 to Day 240
Secondary Outcome Measure Information:
Title
Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months
Description
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.
Time Frame
12 months post study procedure
Title
Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation
Description
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.
Time Frame
Three months after index ablation
Title
Incidence of Completion of Ablation Procedure
Description
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).
Time Frame
From 7 days to 12 months post study procedure
Title
Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure
Description
This endpoint is defined as the absence of documented symptomatic PAF recurrence through 6 months and 12 months post index ablation procedure.
Time Frame
6 and12 months post study procedure
Title
Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation
Description
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.
Time Frame
48 hours post-ablation
Title
Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation
Description
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.
Time Frame
48 hours post-ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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 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.
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.
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 (that is, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Pierre Jais, MD
Organizational Affiliation
Hop. Haut-Lévêque
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ St Jan, Cardiologie
City
Brugge
Country
Belgium
Facility Name
Institute for Clinical and Experimental Medicine (IKEM)
City
Prague
Country
Czechia
Facility Name
HCV HjerteCenter Varde
City
Varde
ZIP/Postal Code
DK-6800
Country
Denmark
Facility Name
HHL Hop. Haut-Lévêque
City
Bordeaux
Country
France
Facility Name
HDB CHU de Nancy
City
Nancy
Country
France
Facility Name
HLG Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
OFM Ospedale Generale Regionale
City
Acquaviva delle Fonti
ZIP/Postal Code
70021
Country
Italy
Facility Name
CCM Centro Cardiologico Monzino
City
Milan
ZIP/Postal Code
20138
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation
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