Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation

NCT06096337 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PF303
• Study Type: interventional
• Target: 484
• Locations: 12 countries
• Sites: 59

Brief Summary

The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.

Conditions

Persistent Atrial Fibrillation

Keywords

Persistent Atrial Fibrillation; Insertable Cardiac Monitor; Pulsed Field Ablation; Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases

Outcome Measures

Primary Outcomes (2)

• Rate of randomized PFA or PFA Assigned subjects with PFA System inserted into the body, during the index or repeat PFA procedure during blanking period, with device or procedure-related Composite Adverse Events that is serious.

  Defined Composite Adverse Events: Day 0 through Day 7: * Gastric motility / pyloric spasm disorders * Heart block * Myocardial infarction * Peripheral or organ thromboembolism * Pulmonary edema * Stroke/ Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Unresolved phrenic nerve palsy / paresis * Vascular access complications Day 0 through Day 30: * Cardiac tamponade / perforation * Cardiovascular or pulmonary adverse event * Death * Pericarditis Day 0 through Month 12: * Atrio-esophageal fistula * Pulmonary vein stenosis

  12-Months

• Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment.

  Defined Treatment Success: PFA and AAD Treatment Arms: • Amiodarone freedom from randomization to Month 12 unless previously an acute or chronic primary effectiveness failure. PFA Treatment Arm: • Acute Success - Isolation of attempted pulmonary veins and left atrial posterior wall during blanking period with PFA system And Chronic Success: Freedom during blanking period to Month 12 of: * Occurrence ≥ 1 hr of asymptomatic or ≥ 30 sec of symptomatic Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Any re-ablation for AF, AFL, or AT * Any electrical cardioversion for AF, AFL, or AT * Any Class I or III AAD use AAD Treatment Arm: Acute Success - Ablation not performed in blanking period Chronic Success - Freedom after blanking period through Month 12 of: * Detectable occurrence ≥ 1 hr of asymptomatic or ≥ 30 sec of symptomatic AF, AFL, or AT * Electrical cardioversion for AF, AFL, or AT * Any ablation for AF, AFL, or AT

  12-Months

Secondary Outcomes (1)

• Atrial fibrillation burden between the pulsed field ablation and anti-arrhythmic drug arm, as the LUX-Dx Insertable Cardiac Monitor measures and defined as proportion of time individual spends in AF during a period (expressed as a percentage).

  12, 24, and 36 Months

Study Arms (2)

Pulsed Field Ablation (PFA)

EXPERIMENTAL

Pulsed Field Ablation (PFA) is used as the initial treatment for subjects with persistent atrial fibrillation (AF)

Device: FARAPULSE™ Pulsed Field Ablation (PFA) System

Anti-Arrhythmic Drug (AAD)

ACTIVE COMPARATOR

Anti-Arrhythmic Drug (AAD) is used as the initial treatment for subjects with persistent atrial fibrillation (AF)

Drug: Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone

Interventions

FARAPULSE™ Pulsed Field Ablation (PFA) System DEVICE

Subjects will undergo a pulsed field ablation procedure using the FARAPULSE™ Pulsed Field Ablation (PFA) System for the isolation of pulmonary veins and posterior wall.

Pulsed Field Ablation (PFA)

Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone DRUG

Anti-Arrhythmic Drugs (AADs) including, Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone will be prescribed and monitored in accordance with local clinical practice and already established guideline-directed therapy for patients with persistent atrial fibrillation (AF).

Anti-Arrhythmic Drug (AAD)

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
• Have symptomatic persistent AF, confirmed by both:
• a. Documentation, within 180 days of randomization, or treatment assignment for roll-in subjects, of either: i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart b. Documentation, such as physician note, of persistent continuous AF for \> 7 days and ≤ 365 days
• Willing and capable of providing informed consent
• Willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
• Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months(i.e., within 180 days of consent

You may not qualify if:

• Treated with AAD (Class I or III) ≤ 6 months (i.e., within 180 days) before enrollment,
• More than 7-day history of therapeutic AAD use (Class I or III), or
• ≥ 24 hours amiodarone, i Note Pill-in-the-pocket AAD use, is permitted.
• Treated with AAD ( Class I or III) \> 6 months (i.e., more than 180 days) before enrollment and experienced AAD failure (adverse drug effects or frequent AF episodes)
• Contraindication to, or unwillingness to use, AADs (Class I and III, excluding amiodarone)
• Contraindication to PFA treatment
• Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra-, and post-procedure to achieve adequate anticoagulation.
• Any of the following atrial conditions:
• Left atrial (LA) anteroposterior diameter ≥ 5.5 cm, or, if LA diameter not available, non-indexed volume \>100 ml, as documented by physician note or imaging (Note: if both values are available, only the LA diameter will be used to confirm eligibility criteria)
• Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided supraventricular tachycardia
• Current atrial myxoma
• Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
• Current left atrial thrombus
• Any of the following cardiovascular conditions:
• History of sustained ventricular tachycardia or any ventricular fibrillation

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (62)

University of Alabama at Birmingham

Birmingham, Alabama, 35249-7333, United States

Location

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Scripps Memorial Hosptial

La Jolla, California, 92037, United States

Location

Stanford University Medical Center

Palo Alto, California, 94305-5406, United States

Location

Cardiology Associates Medical Group, Inc

Ventura, California, 93003, United States

Location

HCA Florida Mercy Hospital

Miami, Florida, 33133, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

St. Joseph's Hospital

Tampa, Florida, 33614, United States

Location

Emory University Hospital

Atlanta, Georgia, 30342, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

Community Heart and Vascular Hospital

Indianapolis, Indiana, 46250, United States

Location

Mercy Hospital Medical Center-Hospital

West Des Moines, Iowa, 50266, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Southcoast Physicians Group

Fall River, Massachusetts, 02720, United States

Location

University of Michigan Hospitals

Ann Arbor, Michigan, 48108, United States

Location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic Foundation-Hospital

Rochester, Minnesota, 55905, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Valley Hospital

Paramus, New Jersey, 07652, United States

Location

Northwell Health

Bay Shore, New York, 11706, United States

Location

Kaleida Health

Buffalo, New York, 14203, United States

Location

Weill Cornell Medical University

New York, New York, 10021, United States

Location

Good Samaritan - Suffern

Suffern, New York, 10901, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0737, United States

Location

Orion Medical

Houston, Texas, 77034, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Chippenham & Johnston-Willis Hospital (CJW)

Richmond, Virginia, 23225, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Royal Adelaide Hospital-Hospital

Adelaide, South Australia, 5000, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Medizinische Univ.-Kliniken Graz-Hospital

Graz, 8036, Austria

Location

St. Jan

Bruges, B-8000, Belgium

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, G1V 4G5, Canada

Location

Klinicki Bolnicki Centar Split

Split, 21 000, Croatia

Location

CHU Grenoble - Hopital Michallon

Grenoble, 38043, France

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, 60431, Germany

Location

Staedtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Queen Mary Hospital

Hong Kong, 999077, Hong Kong

Location

Prince of Wales Hospital

Shatin, 999077, Hong Kong

Location

AOU delle Marche - PO GM Lancisi

Ancona, AN, 60126, Italy

Location

Centro Cardiologico Monzino

Milan, MI, 20138, Italy

Location

Maria Cecilia Hospital SPA

Cotignola, RA, 48010, Italy

Location

Fondazione PTV - Policlinico Tor Vergata

Roma, 00133, Italy

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Taipei Veterans General Hospital-Hospital

Taipei, 1127, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases

Interventions

Drug Delivery Systems; Sotalol; Propafenone; dofetilide; Dronedarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Propiophenones; Ketones; Amiodarone; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Oussama Wazni, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: December 28, 2023
• Primary Completion: February 4, 2026
• Study Completion (Estimated): February 4, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); FR (1); IT (4); TW (1); DE (2); BE (1); AU (1); CA (2); CR (1); US (42); HK (2); SG (1)