Paroxysmal Atrial FibrillationPhase 2REVOLUTIONNCT01353586
REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation
A Phase 2 study testing nMARQ™ System in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 8 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- nMARQ™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 1 Mar 2011to 1 Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Italy2 sites
OFM Ospedale Generale Regionale
Acquaviva delle Fonti, 70021
CCM Centro Cardiologico Monzino
Milan, 20138
About this study
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)
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).
Read the 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
- Being tested
- nMARQ™ System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nMARQ™ SystemDevice
Also called nMARQ™ Circular and Crescent Mapping and Ablation Catheters, Circular/Crescent Ablation Catheters, nMARQ™ Catheters, Circular/Crescent Irrigated catheters
The nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: nMARQ™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Evaluated from Day 91 to Day 240
Secondary outcomes (6)
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.
Measured: 12 months post study 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.
Measured: Three months after index ablation
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).
Measured: From 7 days to 12 months post study procedure
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.
Measured: 6 and12 months post study 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.
Measured: 48 hours post-ablation
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.
Measured: 48 hours post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study start1 Mar 2011
- Primary completion1 Sep 2013
- Study completion1 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Pierre Jais, MD, Principal investigator, Hop. Haut-Lévêque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353586
- Sponsor's protocol ID
- WFCC-133
- Acronym
- REVOLUTION
- Status last verified
- May 2017
- First submitted
- 12 May 2011
- Last updated
- 6 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01353586
- Acronym / sponsor ID
- REVOLUTION / WFCC-133
- Conditions
- Paroxysmal Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 Sep 2013 (actual)
- Study completion
- 1 Sep 2013 (actual)
- First posted
- 13 May 2011 (estimated)
- Results
- Posted 2 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nMARQ™ System | Experimental | Device: nMARQ™ SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nMARQ™ SystemAlso: nMARQ™ Circular and Crescent Mapping and Ablation Catheters, Circular/Crescent Ablation Catheters, nMARQ™ Catheters, Circular/Crescent Irrigated cathetersThe nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon. | Device | nMARQ™ System |
Primary outcome
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.
6 secondary outcomes
Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months
Time frame: 12 months post study procedure
Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation
Time frame: Three months after index ablation
Incidence of Completion of Ablation Procedure
Time frame: From 7 days to 12 months post study procedure
Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure
Time frame: 6 and12 months post study procedure
Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation
Time frame: 48 hours post-ablation
Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation
Time frame: 48 hours post-ablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Pierre Jais, MD principal investigator
Hop. Haut-Lévêque
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nMARQ™ System in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Italy, Belgium, Czechia, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.