Heart zapping vs. pills: which works better for stubborn irregular heartbeat?

NCT ID NCT06096337

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 6 times

Summary

This study tests whether a procedure called pulsed field ablation (PFA) is safer and more effective than anti-arrhythmic drugs as a first treatment for people with persistent atrial fibrillation, a type of irregular heartbeat. About 484 participants will be randomly assigned to receive either the ablation or medication. The goal is to see which approach better controls the heart rhythm and reduces symptoms over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Pulsed field ablation (a procedure using electrical pulses to destroy heart tissue causing irregular rhythm) and anti-arrhythmic drugs (medications like flecainide, sotalol, propafenone, dofetilide, dronedarone)
What this could lead to: If successful, this could show that pulsed field ablation is a better first-line treatment than drugs for persistent atrial fibrillation, potentially reducing symptoms and the need for long-term medication.
What could go wrong: This is an early-stage comparison, and the ablation procedure carries risks like heart block, stroke, or blood vessel damage. The study is not yet complete, so results may not confirm superiority over drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

484 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years of age, or older if specified by local law 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. Treated with AAD (Class I or III) ≤ 6 months (i.e., within 180 days) before enrollment, 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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation cardiovascular disorder heart disorder persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Persistent atrial fibrillation

Contacts and locations

Locations

AOU delle Marche - PO GM Lancisi

Ancona, AN, 60126, Italy
Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States
Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States
Baptist Health Lexington

Lexington, Kentucky, 40503, United States
Bethesda North Hospital

Cincinnati, Ohio, 45242, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
CHU Grenoble - Hopital Michallon

Grenoble, 38043, France
Cardioangiologisches Centrum Bethanien

Frankfurt, 60431, Germany
Cardiology Associates Medical Group, Inc

Ventura, California, 93003, United States
Catholic Medical Center

Manchester, New Hampshire, 03102, United States
Centro Cardiologico Monzino

Milan, MI, 20138, Italy
Chippenham & Johnston-Willis Hospital (CJW)

Richmond, Virginia, 23225, United States
Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Community Heart and Vascular Hospital

Indianapolis, Indiana, 46250, United States
Corewell Health

Grand Rapids, Michigan, 49503, United States
Emory University Hospital

Atlanta, Georgia, 30342, United States
Fondazione PTV - Policlinico Tor Vergata

Roma, 00133, Italy
Good Samaritan - Suffern

Suffern, New York, 10901, United States
HCA Florida Mercy Hospital

Miami, Florida, 33133, United States
Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada
Hospital Universitario La Fe

Valencia, Spain
Institut universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, G1V 4G5, Canada
Intermountain Medical Center

Murray, Utah, 84107, United States
Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States
Kaleida Health

Buffalo, New York, 14203, United States
Klinicki Bolnicki Centar Split

Split, 21 000, Croatia
Maria Cecilia Hospital SPA

Cotignola, RA, 48010, Italy
Mayo Clinic Foundation-Hospital

Rochester, Minnesota, 55905, United States
Medizinische Univ.-Kliniken Graz-Hospital

Graz, 8036, Austria
Memorial Health University Medical Center

Savannah, Georgia, 31404, United States
Mercy Hospital Medical Center-Hospital

West Des Moines, Iowa, 50266, United States
Monash Medical Centre

Clayton, Victoria, 3168, Australia
National Heart Centre Singapore

Singapore, 169609, Singapore
Northwell Health

Bay Shore, New York, 11706, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States
Orion Medical

Houston, Texas, 77034, United States
Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States
Prince of Wales Hospital

Shatin, 999077, Hong Kong
Queen Mary Hospital

Hong Kong, 999077, Hong Kong
Royal Adelaide Hospital-Hospital

Adelaide, South Australia, 5000, Australia
Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States
Scripps Memorial Hosptial

La Jolla, California, 92037, United States
Southcoast Physicians Group

Fall River, Massachusetts, 02720, United States
St. Jan

Bruges, B-8000, Belgium
St. John's Hospital

Springfield, Illinois, 62701, United States
St. Joseph's Hospital

Tampa, Florida, 33614, United States
Staedtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany
Stanford University Medical Center

Palo Alto, California, 94305-5406, United States
Taipei Veterans General Hospital-Hospital

Taipei, 1127, Taiwan
Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35249-7333, United States
University of Michigan Hospitals

Ann Arbor, Michigan, 48108, United States
University of Texas Medical Branch

Galveston, Texas, 77555-0737, United States
Valley Hospital

Paramus, New Jersey, 07652, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States
Weill Cornell Medical University

New York, New York, 10021, United States
York Hospital

York, Pennsylvania, 17403, United States

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