New heart device aims to tame stubborn AFib

NCT ID NCT06735534

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 is testing the FARAPULSE Pulsed Field Ablation system in 376 people with persistent atrial fibrillation (AFib) who have already had a prior ablation. The device uses electrical pulses to destroy the heart tissue causing the abnormal rhythm. The goal is to see if it is safe and effective for a repeat procedure.

What this could mean

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

Active substance: FARAPULSE Pulsed Field Ablation System (a device that uses electrical pulses to destroy heart tissue causing abnormal rhythms)
What this could lead to: If successful, this could provide a safe and effective way to treat persistent atrial fibrillation in people who have already had a prior ablation, potentially reducing the need for long-term medication.
What could go wrong: This is an early-stage, single-arm study with no comparison group, so results may not be definitive. Risks include procedure-related complications like bleeding, heart damage, or stroke.

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

About 376 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jan 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: * ≥ 18 years of age, or older if required by local law * Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation * Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure. * Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device. OR * If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device. * Willing and capable of providing informed consent * Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center Exclusion Criteria: 1. Atrial exclusions - Any of the following atrial conditions: a. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume \>100 ml (physician note or imaging) b. Current atrial myxoma c. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) d. Current left atrial thrombus 2. Cardiovascular exclusions - Any of the following CV 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 implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders, other than LUX-Dx. Patients with a pacemaker are permitted; however, pacemaker-dependent patients are excluded. Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder Left atrial appendage closure devices are excluded, with the exception of WATCHMAN. WATCHMAN is excluded if implanted within 90 days of enrollment 4. Presence of any of the following: • Any prosthetic heart valve, ring or repair • Moderate to severe mitral valve stenosis • More than moderate mitral regurgitation (\>3+) * Moderate to severe aortic stenosis 5. Hypertrophic cardiomyopathy 6. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access 7. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months 8. Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data. 3. Any of the following conditions at baseline: 1. Heart failure associated with NYHA Class III or IV 2. Documented LVEF \< 40% as documented within the previous 12 months 3. Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion 4. Body Mass Index (BMI) \>45.0 5. CHA2DS2-VASc score ≥5 4. Any of the following events within 90 Days of the Consent Date: 1. Coronary disease: Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention within 90 days of consent or any documented history of severe non-revascularize coronary disease 2. Cardiac surgery: Any cardiac surgery 3. Heart failure hospitalization: Heart failure hospitalization 4. Pericardium: Pericarditis or symptomatic pericardial effusion 5. GI bleeding: Gastrointestinal bleeding 6. Neurovascular event: Stroke, TIA, or intracranial bleeding 7. Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event 8. Carotid intervention: Carotid stenting or endarterectomy 9. Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c \> 8.0% 5. Any of the following congenital conditions: 1. Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality 2. Methemoglobinemia: History of known congenital methemoglobinemia 3. G6PD deficiency: History of known G6PD deficiency 6. Any of the following conditions: 1. Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant 2. Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis. Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. Renal: 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 e. Malignancy: Active malignancy (other than squamous cell carcinoma) f. Gastrointestinal: Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration g. Infections: Active systemic infection h. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure i. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) j. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) k. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation. l. Pregnancy: 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 m. General health conditions: 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. n. LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device o. Participation in another trial: Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current 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. p. Life expectancy: Predicted life expectancy less than one (1) year

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation atrial flutter persistent atrial fibrillation

As listed by the trial registrant

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

Persistent atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

41 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AdventHealth Orlando-Hospital
RECRUITING

Orlando, Florida, 32803, United States
AdventHealth Tampa-Hospital
RECRUITING

Tampa, Florida, 33613, United States
Advocate Christ Medical Center-Hospital
RECRUITING

Oak Lawn, Illinois, 60453, United States
Arrhythmia Research Group-Research Facility
RECRUITING

Jonesboro, Arkansas, 72401, United States
Atrium Health Navicent The Medical Center
RECRUITING

Macon, Georgia, 32201, United States
Bethesda North Hospital
RECRUITING

Cincinnati, Ohio, 45242, United States
Christus Trinity Mother Frances Health System
RECRUITING

Tyler, Texas, 75701, United States
Dartmouth Hitchcock Medical Center
RECRUITING

Lebanon, New Hampshire, 03756, United States
Emory University Hospital
RECRUITING

Atlanta, Georgia, 30322, United States
HCA Florida Mercy Hospital
RECRUITING

Miami, Florida, 33133, United States
John Hunter Hospital
RECRUITING

New Lambton Heights, New South Wales, 606-8507, Australia
Johns Hopkins Hospital
RECRUITING

Baltimore, Maryland, 21287, United States
Lovelace Medical Center
RECRUITING

Albuquerque, New Mexico, 87102, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Memorial Health University Medical Center
RECRUITING

Savannah, Georgia, 31404, United States
Mobile Infirmary Medical Center
RECRUITING

Mobile, Alabama, 36607, United States
Naples Comprehensive Health
RECRUITING

Naples, Florida, 34102, United States
National Taiwan University Hospital
RECRUITING

Taipei, Taiwan
Northwell Health
RECRUITING

Manhasset, New York, 11030, United States
Ohio State University Medical Center
RECRUITING

Columbus, Ohio, 43210, United States
Oklahoma Heart Institute
RECRUITING

Tulsa, Oklahoma, 74104, United States
Sentara Norfolk General Hospital
RECRUITING

Norfolk, Virginia, 23507, United States
South Denver Cardiology Associates, PC
RECRUITING

Littleton, Colorado, 80120, United States
Southcoast Physicians Group
RECRUITING

Fall River, Massachusetts, 02720, United States
St. Andrew's War Memorial Hospital
RECRUITING

Brisbane, Queensland, 4001, Australia
St. John's Regional Medical Center
RECRUITING

Oxnard, California, 93030, United States
St. Luke's Boise Medical Center
RECRUITING

Boise, Idaho, 83712, United States
St. Mark's Hospital
RECRUITING

Salt Lake City, Utah, 84124, United States
Stanford University Medical Center
RECRUITING

Stanford, California, 94305, United States
Taipei Veterans General Hospital
RECRUITING

Taipei, Taiwan
Tampa General Hospital
RECRUITING

Tampa, Florida, 33606, United States
Texas Cardiac Arrhythmia Research
RECRUITING

Austin, Texas, 78705, United States
The Alfred Hospital
RECRUITING

Melbourne, Australia
The Royal Melbourne Hospital
RECRUITING

Parkville, Victoria, 3050, Australia
Trident Medical Center
RECRUITING

Charleston, South Carolina, 29406, United States
University of Southern California Hospital
RECRUITING

Los Angeles, California, 90033, United States
Victorian Heart Hospital
RECRUITING

Clayton, Victoria, 3168, Australia
Virtua Health Inc.
RECRUITING

Marlton, New Jersey, 08053, United States
Weill Cornell Medical University
RECRUITING

New York, New York, 10065, United States
Westmead Hospital
RECRUITING

Westmead, New South Wales, 2145, Australia
William Beaumont Hospital-Hospital
RECRUITING

Royal Oak, Michigan, 48073, United States

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