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

NCT05443594 | Completed Results DMC FDA Device

• 1 other identifier: 92836802
• Study Type: interventional
• Target: 669
• Locations: 4 countries
• Sites: 44

Brief Summary

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).

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint (PSE): Event Rate of Safety Events Post Procedure

  Phase 1: Through 7 Days: * Myocardial infarction * Stroke * Transient Ischemic Attack (TIA) * Peripheral or organ thromboembolism * Pulmonary edema * Unresolved phrenic nerve palsy / paresis * Vascular access complications * Heart block * Gastric motility / pyloric spasm disorders Through 30 Days: * Cardiac tamponade / perforation * Pericarditis Through 360 Days Post-Procedure: * PV stenosis * Atrio-esophageal fistula Phase 2 Through 7 Days: * Myocardial infarction * Stroke * Transient Ischemic Attack (TIA) * Peripheral or organ thromboembolism * Pulmonary edema * Unresolved phrenic nerve palsy / paresis * Vascular access complications * Heart block * Gastric motility / pyloric spasm disorders Through 30 Days: * Death * Cardiac tamponade / perforation * Pericarditis * Any PFA system related PFA procedure-related cardiovascular or pulmonary adverse event Through 90 Days: * PV stenosis * Atrio-esophageal fistula

  Phase 1 Index Procedure through 360 Days | Phase 2 Index Procedure through 90 Days (per protocol Primary Safety Endpoint requirements)

• Primary Effectiveness Endpoint: Treatment Success Rate Through Day 360

  Includes both Acute Procedural Success and Chronic Success through Day 360.

  Post-Blanking Period: Day 90 through Day 360

Other Outcomes (2)

• Rate of Persistent AF Chronic Success

  Post-Blanking Period: Day 90 through Day 360

• Rate of Persistent AF Acute Procedural Success

  Assessed through Index Ablation Procedure

Study Arms (2)

Pulsed Field Ablation (Phase 1)

EXPERIMENTAL

PHASE 1 only

Device: Phase 1: FARAPULSE Ablation System

Pulsed Field Ablation (Phase 2)

EXPERIMENTAL

PHASE 2 only

Device: Phase 2: FARAPULSE Ablation System

Interventions

Phase 1: FARAPULSE Ablation System DEVICE

PHASE 1: Pulsed Field Ablation to isolate the Pulmonary Veins and Posterior Wall using the FARAPULSE Ablation System.

Pulsed Field Ablation (Phase 1)

Phase 2: FARAPULSE Ablation System DEVICE

PHASE 2: Pulsed Field Ablation to isolate the Pulmonary Veins, Posterior Wall and Cavo-Tricuspid Isthmus using the FARAPULSE Ablation System.

Pulsed Field Ablation (Phase 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (44)

Grandview Medical Center-Hospital

Birmingham, Alabama, 35243, United States

Location

Banner University Medical Center Phoenix-Hospital

Phoenix, Arizona, 85006, United States

Location

Arrhythmia Research Group-Research Facility

Jonesboro, Arkansas, 72401, United States

Location

Scripps Memorial Hospital-Hospital

La Jolla, California, 92037, United States

Location

Cedars - Sinai Medical Center-Hospital

Los Angeles, California, 90048, United States

Location

University of California, San Francisco-Hospital

San Francisco, California, 94143-0112, United States

Location

Emory University Hospital-Hospital

Atlanta, Georgia, 30322, United States

Location

St. Lukes Idaho Cardiology Associates-Hospital

Boise, Idaho, 83712, United States

Location

Northwestern University-Hospital

Evanston, Illinois, 60208, United States

Location

St. John's Hospital-Hospital

Springfield, Illinois, 62769, United States

Location

St. Vincent's Hospital-Hospital

Indianapolis, Indiana, 46260, United States

Location

Mercy Hospital Medical Center-Hospital

West Des Moines, Iowa, 50266, United States

Location

University of Kansas Hospital-Hospital

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Johns Hopkins Hospital - East Baltimore Campus

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital-Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital-Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Clinic Hospital-Hospital

Burlington, Massachusetts, 01805, United States

Location

St. Luke's Hospital of Kansas City-Hospital

Kansas City, Missouri, 64111, United States

Location

Catholic Medical Center-Hospital

Manchester, New Hampshire, 03102, United States

Location

Valley Hospital-Hospital

Ridgewood, New Jersey, 07450, United States

Location

NYU Langone Health Heart Rhythm Center

New York, New York, 10016, United States

Location

Weill Cornell Medical University-Hospital

New York, New York, 10021, United States

Location

Mount Sinai Medical Center-Hospital

New York, New York, 10029, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

St. Francis Hospital-Hospital

Roslyn, New York, 11576, United States

Location

Bethesda North Hospital-Hospital

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic Foundation-Hospital

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital-Hospital

Columbus, Ohio, 43214, United States

Location

Doylestown Hospital-Hospital

Doylestown, Pennsylvania, 18901, United States

Location

UPMC Heart and Vascular Institute Harrisburg

Harrisburg, Pennsylvania, 17101, United States

Location

Hospital of the University of Pennsylvania-Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Trident Medical Center-Hospital

Charleston, South Carolina, 29406, United States

Location

St. Thomas Research Institute, LLC-Hospital

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center-Hospital

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research-Hospital

Austin, Texas, 78705, United States

Location

Orion Medical - Gulf Commerce Drive

Houston, Texas, 77034, United States

Location

Christus Trinity Mother Frances Health System-Hospital

Tyler, Texas, 75701, United States

Location

Sentara Norfolk General Hospital-Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University Health System-Hospital

Richmond, Virginia, 23219, United States

Location

UZ Brussel (AZ VUB)-Hospital

Brussels, 1090, Belgium

Location

McGill University Health Centre-Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Institut universitaire de Cardiologie et de Pneumologie de Quebec-Hospital

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Clinica Universidad de Navarra-Hospital

Pamplona, 31008, Spain

Location

Related Publications (4)

• Gerstenfeld EP, Schmidt B, Natale A, Nair D, Saliba W, Verma A, Sommer P, Metzner A, Dewland TA, Moss JD, Amin A, Champagne J, Cuoco F, Hounshell T, Issa Z, Turagam M, Brose R, Schwartz T, Raybuck JD, Garlitski A, Mansour M, Reddy VY. Pulsed Field Ablation vs Standard Radiofrequency Ablation for Typical Atrial Flutter: ADVANTAGE AF Trial Substudy. J Am Coll Cardiol. 2026 Feb 6:S0735-1097(26)00055-0. doi: 10.1016/j.jacc.2025.12.081. Online ahead of print.

  PMID: 41653174 DERIVED

• Matsumoto K, van Bragt KA, Kueffer FJ, Mburu W, Tarakji KG. Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation. J Interv Card Electrophysiol. 2026 Apr;69(3):355-363. doi: 10.1007/s10840-025-02124-6. Epub 2025 Sep 10.

  PMID: 40928625 DERIVED

• Reddy VY, Gerstenfeld EP, Schmidt B, Nair D, Natale A, Saliba W, Verma A, Sommer P, Metzner A, Turagam M, Weiner S, Champagne J, Garcio-Bolao I, Calkins H, Olson J, Issa Z, Winner M, Su W, Tomassoni G, Kim J, Hook B, Delurgio DB, Gibson DN, Daccarett M, Patel C, Bhalla K, Shehata M, Harding JD, Cheung JW, Raybuck JD, Roelke S, Schwartz T, Sutton BS, Mansour M; ADVANTAGE-AF Investigators. Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF. J Am Coll Cardiol. 2025 May 6;85(17):1664-1678. doi: 10.1016/j.jacc.2025.03.515.

  PMID: 40306839 DERIVED

• Reddy VY, Gerstenfeld EP, Schmidt B, Andrade JG, Nair D, Natale A, Saliba W, Sommer P, Metzner A, Verma A, Hounshell T, Amin A, Gentlesk P, Weiner S, Cuoco FA, Kim J, Turagam MK, Tomassoni G, Patel C, Issa Z, Shehata M, Anderson AM, Stoltz TJ, Raybuck JD, Schwartz T, Sutton BS, Mansour M; ADVANTAGE AF Investigators. Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous Electrocardiographic Monitoring Follow-Up: ADVANTAGE AF Phase 2. Circulation. 2025 Jul 8;152(1):27-40. doi: 10.1161/CIRCULATIONAHA.125.074485. Epub 2025 Apr 24.

  PMID: 40273320 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Thomas Stoltz
• Organization: Boston Scientific

Thomas.Stoltz@bsci.com

651-582-4000

Study Officials

• Vivek Reddy

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: February 28, 2023
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: December 16, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); US (40); BE (1); CA (2)