A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation

Completed · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).

Key facts

Study ID

NCT05443594

Run by

Boston Scientific Corporation

People needed

669

Starts

2023-02-28

Expected to finish

2025-02-11

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• a. History of sustained ventricular tachycardia or any ventricular fibrillation b. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes c. 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 d. 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

Where it is running

• Grandview Medical Center-Hospital — Birmingham, Alabama, United States
• Banner University Medical Center Phoenix-Hospital — Phoenix, Arizona, United States
• Arrhythmia Research Group-Research Facility — Jonesboro, Arkansas, United States
• Scripps Memorial Hospital-Hospital — La Jolla, California, United States
• Cedars - Sinai Medical Center-Hospital — Los Angeles, California, United States
• University of California, San Francisco-Hospital — San Francisco, California, United States
• Emory University Hospital-Hospital — Atlanta, Georgia, United States
• St. Lukes Idaho Cardiology Associates-Hospital — Boise, Idaho, United States
• Northwestern University-Hospital — Evanston, Illinois, United States
• St. John's Hospital-Hospital — Springfield, Illinois, United States
• St. Vincent's Hospital-Hospital — Indianapolis, Indiana, United States
• Mercy Hospital Medical Center-Hospital — West Des Moines, Iowa, United States
• University of Kansas Hospital-Hospital — Kansas City, Kansas, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Johns Hopkins Hospital - East Baltimore Campus — Baltimore, Maryland, United States
• Massachusetts General Hospital-Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital-Hospital — Boston, Massachusetts, United States
• Lahey Clinic Hospital-Hospital — Burlington, Massachusetts, United States
• St. Luke's Hospital of Kansas City-Hospital — Kansas City, Missouri, United States
• Catholic Medical Center-Hospital — Manchester, New Hampshire, United States
• Valley Hospital-Hospital — Ridgewood, New Jersey, United States
• NYU Langone Health Heart Rhythm Center — New York, New York, United States
• Weill Cornell Medical University-Hospital — New York, New York, United States
• Mount Sinai Medical Center-Hospital — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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