Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2027-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation
• Treatments: Anti-Arrhythmia Agents; Dofetilide; Flecainide; Propafenone; Sotalol

Criteria

Inclusion Criteria:

• 1. Age ≥ 18 years of age, or older if specified by local law

• 2. Have symptomatic persistent AF, confirmed by both:

1. 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

2. 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 of consent

Exclusion Criteria:

• 1. Over the 6 months preceding enrollment, more than 7-day history of therapeutic AAD use (Class I or III), or ≥ 24 hours amiodarone, except for pill-in-the-pocket AAD use, which is permitted. Or, treated with AAD > 6 months preceding enrollment and experienced AAD failure (adverse drug effects or frequent AF episodes)

• 2. 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

• 3. 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

• 4. 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

• 5. Any of the following events 90 days prior to randomization (or Index procedure for 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

• 6. Thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis

• 7. Contraindication to, or unwillingness to use, systemic anticoagulation, AADs (Class I and III, excluding amiodarone which is not allowed during the study), and PFA treatment

• 8. Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx™ ICM device

• 9. 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

• 10. Body Mass Index (BMI) > 45

• 11. Solid organ or hematologic transplant, or currently being evaluated for a transplant

• 12. Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis

• 13. Severe lung disease, or any lung disease involving abnormal blood gases or requiring supplemental oxygen

• 14. Severe pulmonary hypertension during screening assessment

• 15. 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

• 16. Active malignancy at enrollment (other than cutaneous basal cell or squamous cell carcinoma)

• 17. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration

• 18. Known active systemic infection

• 19. Known positive test for Coronavirus Disease 2019 (COVID-19) and disease not clinically resolved

• 20. Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0% in the 90 days prior to randomization (or Index procedure for roll-in subjects)

• 21. Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (>30 pauses per hour)

• 22. Predicted life expectancy less than one (1) year

• 23. 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

• 24. 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

• 25. Has operational LUX-Dx ICM that was inserted more than 6 months prior to enrollment

• 26. Has operational ICM other than a LUX-Dx ICM and does not express a willingness to receive a LUX-Dx ICM for the study

• 27. 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.