Atrial FibrillationPhase 3NCT01824394
nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
A Phase 3 study testing nMARQ Navigation Catheters and NaviStar ThermoCool Catheters in people with Atrial Fibrillation, run by Biosense Webster, Inc..
Trial summary
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with 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
- Atrial Fibrillation
- What is being tested?
- nMARQ Navigation Catheters and NaviStar ThermoCool Catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 481 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 26 Nov 2017
- Phase
- Phase 3
- 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 AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
- Patients who have failed at least one antiarrhythmic drug (AAD; 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 intolerance to the AAD.
- Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.
- Age 18 years or older.
- Signed Patient Informed Consent Form (ICF).
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Who cannot join
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous ablation for atrial fibrillation.
- Patients on amiodarone at any time during the past 3 months prior to enrollment.
- AF episodes lasting > 7 days.
- Any cardiac surgery within the past 60 days (2 months).
- Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
Show all 27Show fewer
- Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).
- Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
- Documented left atrial thrombus on imaging.
- History of a documented thromboembolic event within the past one (1) year.
- Diagnosed atrial myxoma.
- Presence of implanted cardioverter defibrillator (ICD).
- Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction 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.
- Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.
- Acute illness or active systemic infection or sepsis.
- Unstable angina.
- Myocardial infarction within the previous 60 days (2 months).
- Left ventricular ejection fraction <40%.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).
- Life expectancy less than 365 days (12 months).
- Enrollment in an investigational study evaluating another device or drug.
- Uncontrolled heart failure or NYHA Class III or IV heart failure.
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
- Presence of a condition that precludes vascular access.
- Left atrial size >50 mm.
About this study
Official title: reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
- Conditions
- Atrial Fibrillation
- Being tested
- nMARQ Navigation Catheters, NaviStar ThermoCool Catheters
- Keywords
- nMARQ, Atrial Fibrillation, Drug Refractory, Radio Frequency
- 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 Navigation CathetersDevice
NaviStar ThermoCool CathetersDevice
| Study group | Role | What they receive |
|---|---|---|
| nMARQ Catheter | Experimental | nMARQ Catheter System Receives: Device: nMARQ Navigation Catheters |
| NaviStar ThermoCool Catheters | Active comparator | THERMOCOOL® Navigational family of catheters Receives: Device: NaviStar ThermoCool Catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Early Onset Primary Adverse Events
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Measured: 30 days post-procedure
Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study start1 Apr 2013
- Primary completion26 Nov 2017
- Study completion26 Nov 2017
Why it stopped: Business Decision
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824394
- Sponsor's protocol ID
- reMARQable
- Status last verified
- Jan 2025
- First submitted
- 1 Apr 2013
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01824394
- Acronym / sponsor ID
- reMARQable
- Conditions
- Atrial Fibrillation
- Keywords
- nMARQ, Atrial Fibrillation, Drug Refractory, Radio Frequency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 481 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 26 Nov 2017 (actual)
- Study completion
- 26 Nov 2017 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 12 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nMARQ Catheter | Experimental | Device: nMARQ Navigation CathetersnMARQ Catheter System |
| NaviStar ThermoCool Catheters | Active comparator | Device: NaviStar ThermoCool CathetersTHERMOCOOL® Navigational family of catheters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
- Patients who have failed at least one antiarrhythmic drug (AAD; 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 intolerance to the AAD.
- Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.
- Age 18 years or older.
- Signed Patient Informed Consent Form (ICF).
Key exclusion criteria (27 listed)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous ablation for atrial fibrillation.
- Patients on amiodarone at any time during the past 3 months prior to enrollment.
- AF episodes lasting > 7 days.
- Any cardiac surgery within the past 60 days (2 months).
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 Navigation Catheters | Device | nMARQ Catheter |
| NaviStar ThermoCool Catheters | Device | NaviStar ThermoCool Catheters |
Primary outcome
Number of Participants With Early Onset Primary Adverse Events
Time frame: 30 days post-procedure
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population
Time frame: 30 days post-procedure
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nMARQ Navigation Catheters and NaviStar ThermoCool Catheters in people with Atrial Fibrillation, run by Biosense Webster, Inc..
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 6 inclusion and 27 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: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 12 Dec 2018). 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?
Number of Participants With Early Onset Primary Adverse Events (time frame: 30 days 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 4 Feb 2025.