Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
NCT ID: NCT06096337
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
484 participants
INTERVENTIONAL
2023-12-28
2028-02-03
Brief Summary
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Detailed Description
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Once randomization is complete, additional subjects will be enrolled and sequentially assigned to receive PFA treatment to fulfill the number of subjects required for the Primary Safety Endpoint assessment. These additional subjects are referred to as PFA Assigned (Non-Roll-In) Subjects.
Subjects randomized or assigned to PFA treatment will undergo percutaneous ablative pulmonary vein isolation (PVI) and left atrial posterior wall isolation (PWI) using the FARAWAVE™ PFA Catheter (first-line ablation cohort).
Subjects randomized to AAD treatment will be prescribed and monitored in accordance with local clinical practice and already established guideline-directed therapy for patients with persistent atrial fibrillation (AF). In the case of clinical inefficacy, the AAD dose will be up-titrated to the maximum tolerated dose. Thereafter, a change to a second or to a third AAD should be undertaken, insofar as the subject remains within the blanking period, with the goal to completely suppress AF episodes ≥ 30 seconds in duration. If AAD treatment is proven to be ineffective or intolerable outside of the blanking period, subjects can undergo subsequent ablation therapy and be considered part of the "delayed ablation cohort".
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pulsed Field Ablation (PFA)
Pulsed Field Ablation (PFA) is used as the initial treatment for subjects with persistent atrial fibrillation (AF)
FARAPULSE™ Pulsed Field Ablation (PFA) System
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.
Anti-Arrhythmic Drug (AAD)
Anti-Arrhythmic Drug (AAD) is used as the initial treatment for subjects with persistent atrial fibrillation (AF)
Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
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).
Interventions
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FARAPULSE™ Pulsed Field Ablation (PFA) System
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.
Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
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).
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Willing and capable of providing informed consent
4. Willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
5. 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
Exclusion Criteria
1. More than 7-day history of therapeutic AAD use (Class I or III), or
2. ≥ 24 hours amiodarone, i Note Pill-in-the-pocket AAD use, is permitted.
2. 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)
3. Contraindication to, or unwillingness to use, AADs (Class I and III, excluding amiodarone)
4. Contraindication to PFA treatment
5. Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra-, and post-procedure to achieve adequate anticoagulation.
6. Any of the following atrial conditions:
1. 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)
2. Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided supraventricular tachycardia
3. Current atrial myxoma
4. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
5. Current left atrial thrombus
7. Any of the following cardiovascular conditions:
1. History of sustained ventricular tachycardia or any ventricular fibrillation
2. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
3. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, atrial septal patch, atrial septal defect closure device, or patent foramen ovale occluder
4. Valvular disease that is any of the following: i. Symptomatic, ii. Causing or exacerbating congestive heart failure, iii. Associated with abnormal left ventricular (LV) function or hemodynamic measurements
5. Hypertrophic cardiomyopathy
6. Cardiac amyloidosis
7. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
8. Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access
9. Rheumatic heart disease
10. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
11. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
8. Any of the following conditions identified during screening assessments
1. Heart failure associated with New York Heart Association (NYHA) Class IV
2. Left Ventricle Ejection Fraction (LVEF) \< 40%
3. Uncontrolled hypertension (Systolic Blood Pressure \> 160 mmHg or Diastolic Blood Pressure \> 95 mmHg on two (2) BP measurements during screening
9. Any of the following events 90 days prior to randomization (or Index procedure for PFA Assigned or roll-in subjects):
1. Myocardial infarction (MI), unstable angina or coronary intervention
2. Cardiac surgery
3. Heart failure hospitalization
4. Pericarditis or symptomatic pericardial effusion
5. Gastrointestinal bleeding
6. Stroke, TIA, or intracranial bleeding
7. Non-neurologic thromboembolic event
8. Carotid stenting or endarterectomy
10. Known coagulopathy disorder (e.g., von Willbrand's disease, hemophilia)
11. Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx™ ICM device
12. Women of childbearing potential who are pregnant, lactating, not using a reliable form of contraception, or who are planning to become pregnant during the anticipated study period
13. Body Mass Index (BMI) \> 45
14. Solid organ or hematologic transplant, or currently being evaluated for a transplant
15. Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
16. Severe lung disease, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
17. Severe pulmonary hypertension during screening assessment
18. 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
19. Active malignancy at enrollment (other than cutaneous basal cell or squamous cell carcinoma)
20. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
21. Known active systemic infection
22. Uncontrolled diabetes mellitus or a recorded HgbA1c \> 8.0% in the 90 days prior to randomization (or Index procedure for PFA Assigned or roll-in subjects)
23. Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (\>30 pauses per hour)
24. Predicted life expectancy less than one (1) year
25. Currently enrolled in another investigational study or registry that would directly interfere with this 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
26. 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
27. Has operational LUX-Dx ICM that was inserted more than 6 months (i.e., \>180 days) prior to enrollment
28. Has operational ICM other than a LUX-Dx ICM and does not express a willingness to receive a LUX-Dx ICM for the study
29. Individuals who may require an ablation, besides the PV and PW, in the left atrium including, but not limited to, those with Left-Sided Atrioventricular Reentrant Tachycardia (AVRT), Left-Sided Atrial Tachycardia (AT), or Atypical Left-Sided Atrial Flutter.
30. AAD (Class I and III) Drug Naïve Subjects (as defined in criterion #1 and #2), who are PFA Assigned (Non-Roll-in), PFA randomized, or Roll-in with a CHA2DS2-VASc Score ≥ 4
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Oussama Wazni, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Scripps Memorial Hosptial
La Jolla, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Cardiology Associates Medical Group, Inc
Ventura, California, United States
HCA Florida Mercy Hospital
Miami, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
St. John's Hospital
Springfield, Illinois, United States
Community Heart and Vascular Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
West Burlington, Iowa, United States
Mercy Hospital Medical Center-Hospital
West Des Moines, Iowa, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Southcoast Physicians Group
Fall River, Massachusetts, United States
University of Michigan Hospitals
Ann Arbor, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Mayo Clinic Foundation-Hospital
Rochester, Minnesota, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Valley Hospital
Paramus, New Jersey, United States
Northwell Health
Bay Shore, New York, United States
Kaleida Health
Buffalo, New York, United States
Weill Cornell Medical University
New York, New York, United States
Good Samaritan - Suffern
Suffern, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
York Hospital
York, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Orion Medical
Houston, Texas, United States
Christus Trinity Mother Frances Health System
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Chippenham & Johnston-Willis Hospital (CJW)
Richmond, Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Adelaide Hospital-Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Medizinische Univ.-Kliniken Graz-Hospital
Graz, , Austria
St. Jan
Bruges, , Belgium
Hamilton General Hospital
Hamilton, Ontario, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
Klinicki Bolnicki Centar Split
Split, , Croatia
CHU Grenoble - Hopital Michallon
Grenoble, , France
Cardioangiologisches Centrum Bethanien
Frankfurt, , Germany
Staedtisches Klinikum Karlsruhe
Karlsruhe, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
AOU delle Marche - PO GM Lancisi
Ancona, AN, Italy
Centro Cardiologico Monzino
Milan, MI, Italy
Maria Cecilia Hospital SPA
Cotignola, RA, Italy
Fondazione PTV - Policlinico Tor Vergata
Roma, , Italy
National Heart Centre Singapore
Singapore, , Singapore
Hospital Universitario La Fe
Valencia, , Spain
Taipei Veterans General Hospital-Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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PF303
Identifier Type: -
Identifier Source: org_study_id