FARAPULSE Pulsed Field Ablation System in Persistent Atrial Fibrillation

Summary

The purpose of this study to is to evaluate the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System, which uses pulsed electric energy for the treatment of symptomatic persistent atrial fibrillation (irregular heart rhythm). The procedure involved is called cardiac ablation, which is intended to destroy abnormal tissues in the heart that cause atrial fibrillation. This can be done using heat (radiofrequency energy), cold (cryo energy), or pulsed electric energy. The latter (pulsed electric energy) is being tested and considered investigational in this study. The FARAWAVE Catheter will be used to create scar tissue around the openings of blood vessels that bring the blood to the heart from the lungs (pulmonary veins); these vessels are the common source for atrial fibrillation activity. The Catheter will also create scar tissue in the back of the left upper chamber, an area called the posterior wall.

Inclusion Criteria

Age ≥ 18 years of age, or older if specified by local law
Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as:

Inclusion Criteria:

Age ≥ 18 years of age, or older if specified by local law
Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as:
a. Documented: at a minimum a physician's note confirming the arrhythmia symptoms and durations AND, within 180 days of Enrollment Date, either: i. A 24-hour continuous ECG recording confirming continuous AF OR ii. Two ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart b. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one (1) AAD (Class I or III).
c. Persistent: continuous AF for > 7 days and ≤ 365 days
Subjects who are willing and capable of providing informed consent
Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center

Exclusion Criteria:

Any of the following atrial conditions:
Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume >100 ml (by MRI, CT or TTE report or physician note)
Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided SVT
Current atrial myxoma
Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
Current left atrial thrombus
Cardiovascular exclusions - Any of the following CV conditions:
History of sustained ventricular tachycardia or any ventricular fibrillation
AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion, active implantable loop recorder or insertable cardiac monitor at the time of ablation
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. Hypertrophic cardiomyopathy f. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty g. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access h. Rheumatic heart disease i. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality j. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
Any of the following conditions at baseline (Section7.5):
Heart failure associated with NYHA Class III or IV
LVEF < 40%
Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment
Any of the following events within 90 days of the Consent Date:
Myocardial infarction (MI), unstable angina or coronary intervention
Any cardiac surgery
Heart failure hospitalization
Pericarditis or symptomatic pericardial effusion
Gastrointestinal bleeding
Stroke, TIA, or intracranial bleeding
Any non-neurologic thromboembolic event
Carotid stenting or endarterectomy
Thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis
Contraindication to, or unwillingness to use, systemic anticoagulation
Patients who have not been on anticoagulation therapy for at least 4 weeks prior to the ablation procedure
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
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:
Body Mass Index (BMI) > 42.0
Solid organ or hematologic transplant, or currently being evaluated for a transplant
Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
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
Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
Active systemic infection
COVID-19 disease
i. Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date j. Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0% in the 90 days prior to the Consent Date k. Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (>30 pauses per hour)
Predicted life expectancy less than one (1) year
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