| Eligibility |
Inclusion Criteria:
1. Age: = 18 years of age, or older if required by local law
2. Symptomatic, documented, drug-resistant, Atrial Fibrillation
1. Documented: at a minimum a physician's note confirming the arrhythmia symptoms
and durations AND within 180 days of the Enrollment Date one (1) ECG from any
regulatory cleared rhythm monitoring device showing AF
2. Drug-resistant: effectiveness failure of, intolerance to, or specific
contraindication to at least one (1) AAD (Class I, II, III or IV) 1
3. Informed consent: willing and capable of providing informed consent
4. Full participation: willing and capable of participating in all follow-up assessments
and testing associated with this clinical investigation at an approved clinical
investigational center
Exclusion Criteria:
1. Atrial exclusions - Any of the following atrial conditions:
1. Prior atrial ablation: any prior atrial endocardial, epicardial or surgical
ablation procedure for arrhythmia other than ablation for right sided SVT or
cavotricuspid isthmus ablation
2. Atrial myxoma: current atrial myxoma
3. Pulmonary veins: any PV abnormality, stenosis, or stenting (common and middle PVs
are admissible)
4. Atrial thrombus: current left atrial thrombus
5. Long standing persistent AF: continuous AF lasting longer than 12 months
2. Cardiovascular exclusions - Any of the following CV conditions:
1. Ventricular arrhythmia: history of sustained ventricular tachycardia or any
ventricular fibrillation
2. Secondary AF: AF that is secondary to electrolyte imbalance, thyroid disease,
alcohol, or other reversible / non-cardiac causes
3. Cardiac devices and implants: current or anticipated pacemaker, implantable
cardioverter defibrillator or cardiac resynchronization therapy devices,
interatrial baffle, closure device, patch, or patent foramen ovale or ASD
occluder, LA appendage closure, device or occlusion.
4. Clinically significant valvular disease: valvular disease that is any of the
following:
i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associated
with abnormal LV function or hemodynamic measurements e. Cardiomyopathy i.
Hypertrophic cardiomyopathy ii. Cardiac amyloidosis f. Valve prostheses: any
prosthetic heart valve, ring or repair including balloon aortic valvuloplasty g.
Access issues: any IVC filter, known inability to obtain vascular access or other
contraindication to femoral access h. Rheumatic disease: rheumatic heart disease i.
Anticipated cardiac surgery: awaiting cardiac transplantation or other cardiac surgery
within the next 12 months
3. Any of the following conditions at baseline (Section 10.4):
1. Heart failure NYHA Heart failure associated with NYHA IV
2. Ejection fraction: LVEF < 40%
4. Any of the following events within 90 Days of the Consent Date:
1. Coronary disease: myocardial infarction (MI), unstable or coronary intervention
2. Cardiac surgery: any cardiac surgery
3. Heart failure hospitalization: heart failure hospitalization
4. Pericardium: pericarditis or symptomatic pericardial effusion
5. GI bleeding: gastrointestinal bleeding
6. Neurovascular event: stroke, TIA, or intracranial bleeding
7. Thromboembolism: any non-neurologic thromboembolic event
8. Carotid intervention: carotid stenting or endarterectomy
5. Bleeding diathesis: thrombocytosis, thrombocytopenia, disorder of blood clotting or
bleeding diathesis
6. Contraindication to anticoagulation: contraindication to, or unwillingness to use,
systemic anticoagulation
7. Pregnancy: women of childbearing potential who are pregnant, lactating, not using
medical birth control or who are planning to become pregnant during the anticipated
study period
8. Health conditions that in the investigator's medical opinion would prevent
participation in the study, interfere with assessment or therapy, significantly raise
the risk of study participation, or modify outcome data or its interpretation,
including but not limited to:
1. Obesity: Body Mass Index (BMI) > 45.0
2. Transplantation: solid organ or hematologic transplant, or currently being
evaluated for a transplant
3. Diaphragmatic abnormality: any prior history or current evidence of
hemi-diaphragmatic paralysis or paresis
4. Pulmonary: severe lung disease, pulmonary hypertension, or any lung disease
involving abnormal blood gases or requiring supplemental oxygen
5. 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 renal transplant
6. Malignancy: active malignancy (other than cutaneous basal cell or squamous cell
carcinoma)
7. Gastrointestinal: clinically significant gastrointestinal problems involving the
esophagus or stomach including severe or erosive esophagitis, uncontrolled
gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal
ulceration
8. Infections: active systemic infection
9. COVID-19 disease: known positive test for COVID-19 and disease not clinically
resolved
9. Life expectancy: predicted life expectancy less than one (1) year
10. Participation in another trial: subjects who are currently enrolled in another
investigational study or registry that would directly interfere with the current
study, except when the subject is participating in a mandatory governmental registry,
or a purely observational registry with no associated treatments; each instance must
be brought to the attention of the Sponsor to determine eligibility
11. Congenital heart disease: congenital heart disease with any clinically significant
residual anatomic or conduction abnormality
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