Persistent Atrial FibrillationAVANT GUARDNCT06096337
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
A study testing FARAPULSE™ Pulsed Field Ablation (PFA) System and Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 61 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- FARAPULSE™ Pulsed Field Ablation (PFA) System and Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 61 sitesin 13 countries
- Study dates
- 28 Dec 2023to 4 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years of age, or older if specified by local law
- Have symptomatic persistent AF, confirmed by both:
- 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
Who cannot join
- 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
Show all 59Show fewer
- 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
- AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
- 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
- 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
- Hypertrophic cardiomyopathy
- Cardiac amyloidosis
- Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
- Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access
- Rheumatic heart disease
- Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- Any of the following conditions identified during screening assessments
- Heart failure associated with New York Heart Association (NYHA) Class IV
- Left Ventricle Ejection Fraction (LVEF) < 40%
- Uncontrolled hypertension (Systolic Blood Pressure > 160 mmHg or Diastolic Blood Pressure > 95 mmHg on two (2) BP measurements during screening
- Any of the following events 90 days prior to randomization (or Index procedure for PFA Assigned or roll-in subjects):
- Myocardial infarction (MI), unstable angina or coronary intervention
- Cardiac surgery
- Heart failure hospitalization
- Pericarditis or symptomatic pericardial effusion
- Gastrointestinal bleeding
- Stroke, TIA, or intracranial bleeding
- Non-neurologic thromboembolic event
- Carotid stenting or endarterectomy
- Known coagulopathy disorder (e.g., von Willbrand's disease, hemophilia)
- Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx™ ICM device
- 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
- Body Mass Index (BMI) > 45
- Solid organ or hematologic transplant, or currently being evaluated for a transplant
- Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
- Severe lung disease, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
- Severe pulmonary hypertension during screening assessment
- 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
- Active malignancy at enrollment (other than cutaneous basal cell or squamous cell carcinoma)
- Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
- Known active systemic infection
- 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)
- Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (>30 pauses per hour)
- Predicted life expectancy less than one (1) year
- 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
- 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
- Has operational LUX-Dx ICM that was inserted more than 6 months (i.e., >180 days) prior to enrollment
- Has operational ICM other than a LUX-Dx ICM and does not express a willingness to receive a LUX-Dx ICM for the study
- 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.
- 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
Trial locations and contacts
61 sites in 13 countries.
61 sites in 13 countries
United States42 sites
University of Michigan Hospitals
Ann Arbor, Michigan, 48108
Emory University Hospital
Atlanta, Georgia, 30342
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Northwell Health
Bay Shore, New York, 11706
University of Alabama at Birmingham
Birmingham, Alabama, 35249-7333
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kaleida Health
Buffalo, New York, 14203
Bethesda North Hospital
Cincinnati, Ohio, 45242
Cleveland Clinic
Cleveland, Ohio, 44195
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, 43214
Southcoast Physicians Group
Fall River, Massachusetts, 02720
University of Texas Medical Branch
Galveston, Texas, 77555-0737
Corewell Health
Grand Rapids, Michigan, 49503
Orion Medical
Houston, Texas, 77034
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46250
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Scripps Memorial Hosptial
La Jolla, California, 92037
Baptist Health Lexington
Lexington, Kentucky, 40503
Catholic Medical Center
Manchester, New Hampshire, 03102
HCA Florida Mercy Hospital
Miami, Florida, 33133
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Intermountain Medical Center
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Cornell Medical University
New York, New York, 10021
Stanford University Medical Center
Palo Alto, California, 94305-5406
Valley Hospital
Paramus, New Jersey, 07652
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85018
Chippenham & Johnston-Willis Hospital (CJW)
Richmond, Virginia, 23225
Mayo Clinic Foundation-Hospital
Rochester, Minnesota, 55905
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Memorial Health University Medical Center
Savannah, Georgia, 31404
St. John's Hospital
Springfield, Illinois, 62701
Good Samaritan - Suffern
Suffern, New York, 10901
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
St. Joseph's Hospital
Tampa, Florida, 33614
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Christus Trinity Mother Frances Health System
Tyler, Texas, 75701
Cardiology Associates Medical Group, Inc
Ventura, California, 93003
Mercy Hospital Medical Center-Hospital
West Des Moines, Iowa, 50266
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
York Hospital
York, Pennsylvania, 17403
Italy4 sites
AOU delle Marche - PO GM Lancisi
Ancona, AN, 60126
Maria Cecilia Hospital SPA
Cotignola, RA, 48010
Centro Cardiologico Monzino
Milan, MI, 20138
Fondazione PTV - Policlinico Tor Vergata
Roma, 00133
Australia2 sites
Royal Adelaide Hospital-Hospital
Adelaide, South Australia, 5000
Monash Medical Centre
Clayton, Victoria, 3168
Canada2 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5
Germany2 sites
Cardioangiologisches Centrum Bethanien
Frankfurt, 60431
Staedtisches Klinikum Karlsruhe
Karlsruhe, 76133
Hong Kong2 sites
Queen Mary Hospital
Hong Kong, 999077
Prince of Wales Hospital
Shatin, 999077
About this study
Official title: A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
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.
Read the detailed description
This is a prospective, randomized, multi-center, global, pivotal Investigational device exemption (IDE) study. Subjects with persistent atrial fibrillation will be randomized or assigned to either pulsed field ablation (PFA) or Versus Anti-Arrhythmic Drug (AAD) treatment.
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
- Persistent Atrial Fibrillation
- Being tested
- FARAPULSE™ Pulsed Field Ablation (PFA) System, Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
- Keywords
- Persistent Atrial Fibrillation, Insertable Cardiac Monitor, Pulsed Field Ablation, Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAPULSE™ Pulsed Field Ablation (PFA) SystemDevice
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 DronedaroneDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Field Ablation (PFA) | Experimental | Pulsed Field Ablation (PFA) is used as the initial treatment for subjects with persistent atrial fibrillation (AF) Receives: 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) Receives: Drug: Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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).
Atrial Fibrillation (AF) burden, measured by the LUX-Dx Insertable Cardiac Monitor (ICM) between the 2 randomized groups:
- Pulsed Field Ablation (PFA) as initial treatment for subjects with persistent AF
- Anti-Arrhythmic Drug (AAD) as initial treatment for subjects with persistent AF
Defined AF Burden is proportion of AF time during a period (expressed as a percentage).
Measured: 12, 24, and 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start28 Dec 2023
- Primary completion4 Feb 2026
- Study completion4 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oussama Wazni, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096337
- Sponsor's protocol ID
- PF303
- Acronym
- AVANT GUARD
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wazni OM, Chun KRJ, Nair DG, Anic A, Duytschaever M, Chrispin J, Amin A, Ajijola OA, Gibson DN, Mansour M, Piccini JP, Natale A, Badin A, Osca J, Dukes J, Bhalla K, Hussein A, Senn T, Weiner S, Sood N, Dello Russo A, Sadhu A, Meyers J, Trulock K, Tam MTK, DeLurgio DB, Champagne J, Iacopino S, Kwan B, Albrecht EM, McCammon S, Garlitski AC, Sutton BS, Stein KM, Andrade JG; AVANT GUARD Study Investigators. Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation. N Engl J Med. 2026 Jun 25;394(24):2407-2418. doi: 10.1056/NEJMoa2600929. Epub 2026 Apr 25.
PubMed 42041224
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06096337
- Acronym / sponsor ID
- AVANT GUARD / PF303
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Persistent Atrial Fibrillation, Insertable Cardiac Monitor, Pulsed Field Ablation, Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2028 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized, multi-center, global, pivotal Investigational device exemption (IDE) study. Subjects with persistent atrial fibrillation will be randomized or assigned to either pulsed field ablation (PFA) or Versus Anti-Arrhythmic Drug (AAD) treatment.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field Ablation (PFA) | Experimental | Device: FARAPULSE™ Pulsed Field Ablation (PFA) SystemPulsed Field Ablation (PFA) is used as the initial treatment for subjects with persistent atrial fibrillation (AF) |
| Anti-Arrhythmic Drug (AAD) | Active comparator | Drug: Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and DronedaroneAnti-Arrhythmic Drug (AAD) is used as the initial treatment for subjects with persistent atrial fibrillation (AF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years of age, or older if specified by local law
- Have symptomatic persistent AF, confirmed by both:
- 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
Key exclusion criteria (59 listed)
- Treated with AAD (Class I or III) ≤ 6 months (i.e., within 180 days) before enrollment,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FARAPULSE™ Pulsed Field Ablation (PFA) SystemSubjects will undergo a pulsed field ablation procedure using the FARAPULSE™ Pulsed Field Ablation (PFA) System for the isolation of pulmonary veins and posterior wall. | Device | Pulsed Field Ablation (PFA) |
| Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and DronedaroneAnti-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). | Drug | Anti-Arrhythmic Drug (AAD) |
Primary outcome
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.
Time frame: 12-Months
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
Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment.
Time frame: 12-Months
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
1 secondary outcome
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).
Time frame: 12, 24, and 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Derived from this study: PubMed 42041224Wazni OM, Chun KRJ, Nair DG, Anic A, Duytschaever M, Chrispin J, Amin A, Ajijola OA, Gibson DN, Mansour M, Piccini JP, Natale A, Badin A, Osca J, Dukes J, Bhalla K, Hussein A, Senn T, Weiner S, Sood N, Dello Russo A, Sadhu A, Meyers J, Trulock K, Tam MTK, DeLurgio DB, Champagne J, Iacopino S, Kwan B, Albrecht EM, McCammon S, Garlitski AC, Sutton BS, Stein KM, Andrade JG; AVANT GUARD Study Investigators. Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation. N Engl J Med. 2026 Jun 25;394(24):2407-2418. doi: 10.1056/NEJMoa2600929. Epub 2026 Apr 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oussama Wazni, M.D. principal investigator
The Cleveland Clinic
61 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FARAPULSE™ Pulsed Field Ablation (PFA) System and Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 61 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 59 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Italy, Australia, Canada, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12-Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06096337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.