Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation

Not Applicable

Completed

Conditions: Persistent Atrial Fibrillation

Interventions: Device: Ablation

Registration Number: NCT04170621

Lead Sponsor: Farapulse, Inc.

Brief Summary: PersAFOne:

Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation

Detailed Description: This is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 75 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

Inclusion Criteria

Study subjects are required to meet all the following inclusion criteria to participate in this study:

Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:
1. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent.
2. ECG-documented first episode of persistent AF, lasting longer than 7 days but not longer than 365 days
3. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF
Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
Patient participation requirements:
1. Lives locally
2. Is willing and capable of providing Informed Consent to undergo study procedures
3. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

Exclusion Criteria

Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:

AF that is:
1. Paroxysmal (longest AF episode < 7days)
2. Longstanding (has persisted > 12 months or that does not respond to cardioversion if < 12 months)
3. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
Any of the following cardiac procedures, implants or conditions:
1. Clinically significant arrhythmias other than AF, AFL or AT
2. Hemodynamically significant valvular disease
3. Prosthetic heart valve
4. NYHA Class III or IV CHF
5. Previous endocardial or epicardial ablation or surgery for AF
6. Atrial or ventricular septal defect closure
7. Atrial myxoma
8. Left atrial appendage device or occlusion
9. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
10. Significant or symptomatic hypotension
11. Bradycardia or chronotropic incompetence
12. History of pericarditis
13. History of rheumatic fever
14. History of congenital heart disease with any residual anatomic or conduction abnormality
Any of the following within 3 months of enrollment:
1. Myocardial infarction
2. Unstable angina
3. Percutaneous coronary intervention
4. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)
5. Heart failure hospitalization
6. Stroke or TIA
7. Clinically significant bleeding
8. Pericarditis or pericardial effusion
9. Left atrial thrombus
History of blood clotting or bleeding abnormalities.
Contraindication to, or unwillingness to use, systemic anticoagulation
Contraindications to CT or MRI
Sensitivity to contrast media not controlled by premedication
Women of childbearing potential who are pregnant, lactating or not using birth control
Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to
1. Body mass index (BMI) > 40
2. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
3. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
4. Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
5. Active malignancy or history of treated cancer within 24 months of enrollment
6. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
7. Clinically significant infection
8. Predicted life expectancy less than one year
Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
Current or anticipated enrollment in any other clinical study
Employment by FARAPULSE or the same hospital department or office of any investigator, or a family member of any of the preceding groups.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FARAPULSE Endocardial Ablation	Ablation	Ablation using the FARAPULSE Endocardial Multi Ablation System

Primary Outcome Measures

Name	Time	Method
Safety at 30 Days	30 Days	Occurrence of primary safety events at 30 days post procedure: death, MI, stroke/TIA, thromboembolism, pericarditis/tamponade, vascular access complications, hospitalization, heart block, PV stenosis, atriosesphageal fistula

Secondary Outcome Measures