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

Plain English Summary

Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation is a Not Applicable clinical trial sponsored by Boston Scientific Corporation studying Persistent Atrial Fibrillation. This study tests a new heart ablation technique called Pulsed Field Ablation (PFA) against standard anti-arrhythmic drug (AAD) therapy. It is for adults diagnosed with persistent Atrial Fibrillation (AFib) who are experiencing symptoms. Participants will be randomly assigned to either the PFA procedure or receive AADs, and will be monitored for 12 months. Current alternatives include AADs, other ablation methods, or lifestyle changes, but this study focuses on PFA as a first-line treatment. The trial aims to enroll 484 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with symptomatic persistent AFib confirmed by recent ECGs. Individuals must be willing and able to undergo the study procedures and provide informed consent. Cannot have received AADs within the last 6 months, or have certain heart conditions like enlarged atria, prior ablations (except specific types), or significant valve disease. Excludes individuals with recent heart attack, stroke, uncontrolled high blood pressure, severe lung disease, or a BMI over 45. This trial is studying Persistent Atrial Fibrillation, so participants generally need a confirmed diagnosis.

What They're Measuring

Treatment success means that the chosen therapy (either PFA or AADs) effectively controlled the irregular heart rhythm without causing serious complications within the first year. The specific primary outcome measures are: 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. (12-Months); Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment. (12-Months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it investigates a potentially less invasive and more targeted ablation method (PFA) as an initial treatment for persistent AFib, aiming to improve patient outcomes and reduc This research targets Persistent Atrial Fibrillation, where improved treatment options are needed.

Investor Insight

This trial signals strong investor interest in innovative cardiovascular technologies like PFA, a rapidly growing market driven by the high prevalence of AFib and the demand for safer, more effective

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of both PFA and AADs for your specific condition. Understand that you will be randomly assigned to one of the two treatments, and participation involves regular check-ups and monitoring. Be prepared for potential follow-up procedures or adjustments to your treatment based on how well it's working. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 484 participants

Interventions

• DEVICE: 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.
• DRUG: 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).

Primary Outcomes

• 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. (12-Months)
• Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment. (12-Months)

Secondary Outcomes

• 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)

Full Eligibility Criteria

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

Trial Locations

• 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
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Atrial Fibrillation
• Arrhythmia
• Heart Rhythm Disorders
• Cardiovascular Disease
• Persistent Atrial Fibrillation
• Supraventricular Tachycardia
• Congestive Heart Failure
• Hypertension
• Stroke
• Pulmonary Vein Stenosis

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