Phase
Condition
Chest Pain
Atrial Fibrillation
Arrhythmia
Treatment
Ablation Treatment
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: ≥ 18 years of age, or older if required by local law
Symptomatic, documented, drug-resistant, Atrial Fibrillation
Documented: at a minimum a physician's note confirming the arrhythmia symptomsand durations AND within 180 days of the Enrollment Date one (1) ECG from anyregulatory cleared rhythm monitoring device showing AF
Drug-resistant: effectiveness failure of, intolerance to, or specificcontraindication to at least one (1) AAD (Class I, II, III or IV) 1
Informed consent: willing and capable of providing informed consent
Full participation: willing and capable of participating in all follow-upassessments and testing associated with this clinical investigation at an approvedclinical investigational center
Exclusion
Exclusion Criteria:
Atrial exclusions - Any of the following atrial conditions:
Prior atrial ablation: any prior atrial endocardial, epicardial or surgicalablation procedure for arrhythmia other than ablation for right sided SVT orcavotricuspid isthmus ablation
Atrial myxoma: current atrial myxoma
Pulmonary veins: any PV abnormality, stenosis, or stenting (common and middlePVs are admissible)
Atrial thrombus: current left atrial thrombus
Long standing persistent AF: continuous AF lasting longer than 12 months
Cardiovascular exclusions - Any of the following CV conditions:
Ventricular arrhythmia: history of sustained ventricular tachycardia or anyventricular fibrillation
Secondary AF: AF that is secondary to electrolyte imbalance, thyroid disease,alcohol, or other reversible / non-cardiac causes
Cardiac devices and implants: current or anticipated pacemaker, implantablecardioverter defibrillator or cardiac resynchronization therapy devices,interatrial baffle, closure device, patch, or patent foramen ovale or ASDoccluder, LA appendage closure, device or occlusion.
Clinically significant valvular disease: valvular disease that is any of thefollowing: i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associatedwith abnormal LV function or hemodynamic measurements e. Cardiomyopathy i.Hypertrophic cardiomyopathy ii. Cardiac amyloidosis f. Valve prostheses: anyprosthetic heart valve, ring or repair including balloon aortic valvuloplasty g.Access issues: any IVC filter, known inability to obtain vascular access or othercontraindication to femoral access h. Rheumatic disease: rheumatic heart disease i.Anticipated cardiac surgery: awaiting cardiac transplantation or other cardiacsurgery within the next 12 months
Any of the following conditions at baseline (Section 10.4):
Heart failure NYHA Heart failure associated with NYHA IV
Ejection fraction: LVEF < 40%
Any of the following events within 90 Days of the Consent Date:
Coronary disease: myocardial infarction (MI), unstable or coronary intervention
Cardiac surgery: any cardiac surgery
Heart failure hospitalization: heart failure hospitalization
Pericardium: pericarditis or symptomatic pericardial effusion
GI bleeding: gastrointestinal bleeding
Neurovascular event: stroke, TIA, or intracranial bleeding
Thromboembolism: any non-neurologic thromboembolic event
Carotid intervention: carotid stenting or endarterectomy
Bleeding diathesis: thrombocytosis, thrombocytopenia, disorder of blood clotting orbleeding diathesis
Contraindication to anticoagulation: contraindication to, or unwillingness to use,systemic anticoagulation
Pregnancy: women of childbearing potential who are pregnant, lactating, not usingmedical birth control or who are planning to become pregnant during the anticipatedstudy period
Health conditions that in the investigator's medical opinion would preventparticipation in the study, interfere with assessment or therapy, significantlyraise the risk of study participation, or modify outcome data or its interpretation,including but not limited to:
Obesity: Body Mass Index (BMI) > 45.0
Transplantation: solid organ or hematologic transplant, or currently beingevaluated for a transplant
Diaphragmatic abnormality: any prior history or current evidence ofhemi-diaphragmatic paralysis or paresis
Pulmonary: severe lung disease, pulmonary hypertension, or any lung diseaseinvolving abnormal blood gases or requiring supplemental oxygen
Renal: renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renaltransplant
Malignancy: active malignancy (other than cutaneous basal cell or squamous cellcarcinoma)
Gastrointestinal: clinically significant gastrointestinal problems involvingthe esophagus or stomach including severe or erosive esophagitis, uncontrolledgastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenalulceration
Infections: active systemic infection
COVID-19 disease: known positive test for COVID-19 and disease not clinicallyresolved
Life expectancy: predicted life expectancy less than one (1) year
Participation in another trial: subjects who are currently enrolled in anotherinvestigational study or registry that would directly interfere with the currentstudy, except when the subject is participating in a mandatory governmentalregistry, or a purely observational registry with no associated treatments; eachinstance must be brought to the attention of the Sponsor to determine eligibility
Congenital heart disease: congenital heart disease with any clinically significantresidual anatomic or conduction abnormality
Study Design
Study Description
Connect with a study center
Na Homolce Hospital
Prague, 15030
CzechiaSite Not Available
Na Homolce Hospital
Prague 3067696, 15030
CzechiaSite Not Available
Mater Private Hospital
Dublin, 7 D07 RD8P
IrelandSite Not Available
Mater Private Hospital
Dublin 2964574, 7 D07 RD8P
IrelandSite Not Available
Clínica Universidad de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
Clínica Universidad de Navarra
Pamplona 3114472, Navarre 3115609 31008
SpainSite Not Available

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