nMARQâ„¢ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation (NCT01824394) | Clinical Trial Compass
TerminatedPhase 3
nMARQâ„¢ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Stopped: Business Decision
481 participantsStarted 2013-04-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
Number of Participants With Early Onset Primary Adverse Events
Timeframe: 30 days post-procedure
2
Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population