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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06096337
Other study ID # PF303
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 28, 2023
Est. completion date December 30, 2027

Study information

Verified date June 2024
Source Boston Scientific Corporation
Contact Boston Scientific
Phone 800-272-1001
Email monitortroubleshooting@cdxbsci.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

This is a prospective, randomized, multi-center, global, pivotal Investigational device exemption (IDE) study. Subjects with persistent atrial fibrillation will be randomized to either pulsed field ablation (PFA) or Versus Anti-Arrhythmic Drug (AAD) treatment. Subjects randomized 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). Cardioversion is recommended during the initiation of antiarrhythmic drugs for subjects who are not in sinus rhythm. 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. It is advisable to perform cardioversion with each dose titration or when changing the AAD regimen. 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".


Recruitment information / eligibility

Status Recruiting
Enrollment 387
Est. completion date December 30, 2027
Est. primary completion date December 25, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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, and Dofetilide
Anti-Arrhythmic Drugs (AADs) including, Flecainide, Sotalol, Propafenone, and Dofetilide will be prescribed and monitored in accordance with local clinical practice and already established guideline-directed therapy for patients with persistent atrial fibrillation (AF).

Locations

Country Name City State
Australia The Prince Charles Hospital Chermside Queensland
Australia Monash Medical Centre Clayton Victoria
Belgium St. Jan Brugge
Canada Hamilton General Hospital Hamilton Ontario
Canada Institut universitaire de Cardiologie et de Pneumologie de Quebec Québec Quebec
Canada Vancouver General Hospital Vancouver
Croatia Klinicki Bolnicki Centar Split Split
Germany Cardioangiologisches Centrum Bethanien Frankfurt
Italy AOU delle Marche - PO GM Lancisi Ancona AN
Italy Maria Cecilia Hospital SPA Cotignola RA
Italy Centro Cardiologico Monzino Milano MI
Singapore National Heart Centre Singapore Singapore
Spain Hospital Universitario La Fe Valencia
United States University of Michigan Hospitals Ann Arbor Michigan
United States Memorial Mission Hospital-Hospital Asheville North Carolina
United States Emory University Hospital Atlanta Georgia
United States Texas Cardiac Arrhythmia Research Austin Texas
United States Johns Hopkins Hospital Baltimore Maryland
United States Northwell Health Bay Shore New York
United States University of Alabama at Birmingham Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Kaleida Health Buffalo New York
United States Medical University of South Carolina Charleston South Carolina
United States Bethesda North Hospital Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States OhioHealth Research and Innovation Institute - Riverside Methodist Hospital Columbus Ohio
United States Duke University Medical Center Durham North Carolina
United States University of Texas Medical Branch Galveston Texas
United States Corewell Health Grand Rapids Michigan
United States Orion Medical Houston Texas
United States Community Heart and Vascular Hospital Indianapolis Indiana
United States Arrhythmia Research Group Jonesboro Arkansas
United States Catholic Medical Center Manchester New Hampshire
United States HCA Florida Mercy Hospital Miami Florida
United States Aurora St. Luke's Medical Center Milwaukee Wisconsin
United States Intermountain Medical Center Murray Utah
United States Vanderbilt University Medical Center Nashville Tennessee
United States Weill Cornell Medical University New York New York
United States Stanford University Medical Center Palo Alto California
United States Banner University Medical Center Phoenix Phoenix Arizona
United States Phoenix Cardiovascular Research Group Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Southcoast Physicians Group Providence Rhode Island
United States Chippenham & Johnston-Willis Hospital (CJW) Richmond Virginia
United States Mayo Clinic Foundation-Hospital Rochester Minnesota
United States Sarasota Memorial Hospital Sarasota Florida
United States Memorial Health University Medical Center Savannah Georgia
United States St. John's Hospital Springfield Illinois
United States Good Samaritan - Suffern Suffern New York
United States Tallahassee Memorial Hospital Tallahassee Florida
United States St. Joseph's Hospital Tampa Florida
United States Oklahoma Heart Institute Tulsa Oklahoma
United States Christus Trinity Mother Frances Health System Tyler Texas
United States Cardiology Associates Medical Group, Inc Ventura California
United States University of Iowa Hospitals and Clinics West Burlington Iowa
United States Mercy Hospital Medical Center-Hospital West Des Moines Iowa
United States Wake Forest University School of Medicine Winston-Salem North Carolina
United States York Hospital York Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Croatia,  Germany,  Italy,  Singapore,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of intent to treat subjects, randomized to PFA with PFA System inserted into body, during index procedure or repeat PFA procedure during blanking period, with device or procedure-related Composite Adverse Events that is serious. Composite Adverse Events are defined as follows:
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
12-Months
Primary Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment. Rate of Intent to Treat subjects with Treatment Success through Month 12 assessment
PFA Treatment Arm:
Acute Success - Isolation of all attempted pulmonary veins and left atrial posterior wall with PFA system
Chronic Success: Freedom from amiodarone use and after the blanking period through the Month-12 assessment occurrence of:
Occurrence = 1 hour of asymptomatic or = 30 seconds 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 during the blanking period
Chronic Success - Freedom from amiodarone use and after the blanking period through the Month 12 assessment of occurrence of:
Detectable occurrence = 1 hour of asymptomatic or = 30 seconds of symptomatic AF, AFL, or AT
Electrical cardioversion for AF, AFL, or AT
Any ablation for AF, AFL, or AT
12-Months
Secondary Atrial fibrillation burden between the pulsed field ablation and anti-arrhythmic drug arm, as measured by the LUX-Dx Insertable Cardiac Monitor and defined as the proportion of time an individual spends in AF during a period (expressed as a percentage). Atrial Fibrillation (AF) burden, as 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
AF Burden is defined as the proportion of time an individual spends in AF during a period (expressed as a percentage).
12, 24, and 36 Months
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