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The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Catheter Endocardial Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal and persistent atrial fibrillation (AF).
Full description
This study is a prospective, multicenter, two-cohort, non-randomized clinical investigation. Eligible participants with drug-resistant paroxysmal or persistent AF who are clinically indicated for an endocardial cardiac ablation procedure will undergo nsPFA ablation with the CellFX Catheter Endocardial Ablation System. The primary endpoints will be assessed at 6 months after the ablation procedure. The paroxysmal AF cohort and the persistent AF cohort will be assessed independently for success.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
A diagnosis of recurrent drug-resistant (Class I - IV) symptomatic paroxysmal or persistent AF:
a. Symptomatic paroxysmal AF is defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following:
i. Physician's note indicating recurrent self-terminating AF prior to enrollment; AND
ii. At least one (1) ECG documented AF episode from any form of rhythm monitoring within six (6) months prior to enrollment
OR
b. Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
i. physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment;
AND either
iia. any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrollment; OR
iib. Two (2) ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment.
Exclusion Criteria:
Left atrial diameter ≥5.5 cm (anteroposterior)
Any of the following within 3 months prior to enrollment:
Any of the following within 6 months prior to enrollment:
Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, Left atrial appendage occlusion)
Planned Left Atrial Appendage (LAA) closure procedure, Transcatheter Aortic Valve Replacement (TAVR), Mitraclip, Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO) closure, Triclip or implant of an Implantable Loop Recorder (ILR), permanent pacemaker, biventricular pacemaker, or any implantable cardiac defibrillator (with or without biventricular pacing function) during or for any time during the follow-up period
Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
Documented left atrial (LA) thrombus by imaging within 48 hours of the procedure.
Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).
Prior diagnosis of pulmonary vein stenosis
Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
Moderate to severe mitral valve stenosis
More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)
New York Heart Association (NYHA) Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measured by acceptable cardiac testing (e.g., TTE)
History of pulmonary hypertension with pulmonary systolic artery pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease
Rheumatic heart disease
Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)
Active systemic infection
Hypertrophic cardiomyopathy
Atrial myxoma
Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
History of abnormal bleeding and/or clotting disorder
Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease, fragility)
Body Mass Index (BMI) > 40.0
Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder)
Life expectancy less than one year
Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor
Unwilling or unable to comply fully with study procedures and follow-up
Primary purpose
Allocation
Interventional model
Masking
375 participants in 1 patient group
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Central trial contact
Micki Weisman; William A. Knape
Data sourced from clinicaltrials.gov
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