A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
NCT ID: NCT05443594
Last Updated: 2025-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
669 participants
INTERVENTIONAL
2023-02-28
2025-02-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pulsed Field Ablation (Phase 1)
PHASE 1 only
Phase 1: FARAPULSE Ablation System
PHASE 1: Pulsed Field Ablation to isolate the Pulmonary Veins and Posterior Wall using the FARAPULSE Ablation System.
Pulsed Field Ablation (Phase 2)
PHASE 2 only
Phase 2: FARAPULSE Ablation System
PHASE 2: Pulsed Field Ablation to isolate the Pulmonary Veins, Posterior Wall and Cavo-Tricuspid Isthmus using the FARAPULSE Ablation System.
Interventions
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Phase 1: FARAPULSE Ablation System
PHASE 1: Pulsed Field Ablation to isolate the Pulmonary Veins and Posterior Wall using the FARAPULSE Ablation System.
Phase 2: FARAPULSE Ablation System
PHASE 2: Pulsed Field Ablation to isolate the Pulmonary Veins, Posterior Wall and Cavo-Tricuspid Isthmus using the FARAPULSE Ablation System.
Eligibility Criteria
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Inclusion Criteria
2. Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as:
a. Documented: at a minimum a physician's note confirming the arrhythmia symptoms and durations AND, within 180 days of Enrollment Date, either: i. A 24-hour continuous ECG recording confirming continuous AF OR ii. Two ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart b. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one (1) AAD (Class I or III).
c. Persistent: continuous AF for \> 7 days and ≤ 365 days
3. Subjects who are willing and capable of providing informed consent
4. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
1. Age ≥ 18 years of age, or older if specified by local law
2. Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as:
a. Documented: at a minimum a physician's note confirming the arrhythmia symptoms and durations AND, within 180 days of Enrollment Date, either: i. A 24-hour continuous ECG recording confirming continuous AF OR ii. Two ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart b. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one (1) AAD (Class I or III).
c. Persistent: continuous AF for \> 7 days and ≤ 365 days
3. Subjects who are willing and capable of providing informed consent
4. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
Exclusion Criteria
1. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume \>100 ml (by MRI, CT or TTE report or physician note)
2. Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided SVT
3. Current atrial myxoma
4. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
5. Current left atrial thrombus
2. Cardiovascular exclusions - Any of the following CV conditions:
a. History of sustained ventricular tachycardia or any ventricular fibrillation b. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes c. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion, active implantable loop recorder or insertable cardiac monitor at the time of ablation d. Valvular disease that is any of the following: i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associated with abnormal LV function or hemodynamic measurements e. Hypertrophic cardiomyopathy f. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty g. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access h. Rheumatic heart disease i. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality j. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
3. Any of the following conditions at baseline (Section7.5):
1. Heart failure associated with NYHA Class III or IV
2. LVEF \< 40%
3. Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 95 mmHg on two (2) BP measurements at baseline assessment
4. Any of the following events within 90 days of the Consent Date:
1. Myocardial infarction (MI), unstable angina or coronary intervention
2. Any cardiac surgery
3. Heart failure hospitalization
4. Pericarditis or symptomatic pericardial effusion
5. Gastrointestinal bleeding
6. Stroke, TIA, or intracranial bleeding
7. Any non-neurologic thromboembolic event
8. Carotid stenting or endarterectomy
5. Thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis
6. Contraindication to, or unwillingness to use, systemic anticoagulation
7. Patients who have not been on anticoagulation therapy for at least 4 weeks prior to the ablation procedure
8. 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
9. 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, including but not limited to:
1. Body Mass Index (BMI) \> 42.0
2. Solid organ or hematologic transplant, or currently being evaluated for a transplant
3. Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
4. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
5. 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
6. Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
7. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
8. Active systemic infection
9. COVID-19 disease
i. Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date j. Uncontrolled diabetes mellitus or a recorded HgbA1c \> 8.0% in the 90 days prior to the Consent Date k. Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (\>30 pauses per hour)
10. Predicted life expectancy less than one (1) year
11. 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
\[PHASE 2\] --------------------------------------------
1. Any of the following atrial conditions:
1. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume \>100 ml (by MRI, CT or TTE report or physician note)
2. Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided SVT
3. Current atrial myxoma
4. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
5. 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 pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion, active implantable loop recorder or insertable cardiac monitor at the time of ablation
4. Valvular disease that is any of the following:
i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associated with abnormal LV function or hemodynamic measurements e. Hypertrophic cardiomyopathy f. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty g. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access h. Rheumatic heart disease i. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months j. Nitroglycerin intolerance: Known adverse drug reaction to nitroglycerin k. Coronary disease: Known severe non-revascularizable coronary disease l. Stents: Pre-existing right coronary artery stent
3. Any of the following conditions at baseline (Section7.5):
1. Heart failure associated with NYHA Class III or IV
2. LVEF \< 40%
3. Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 95 mmHg on two (2) BP measurements at baseline assessment
4. Ventricular dysfunction: Right ventricular dysfunction
4. Any of the following events within 90 days of the Consent Date:
1. Myocardial infarction (MI), unstable angina or coronary intervention
2. Any cardiac surgery
3. Heart failure hospitalization
4. Pericarditis or symptomatic pericardial effusion
5. Gastrointestinal bleeding
6. Stroke, TIA, or intracranial bleeding
7. Any non-neurologic thromboembolic event
8. Carotid stenting or endarterectomy
5. Thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis
6. Contraindication to, or unwillingness to use, systemic anticoagulation
7. Patients who have not been on anticoagulation therapy for at least 4 weeks prior to the ablation procedure
8. 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
9. 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, including but not limited to:
1. Body Mass Index (BMI) \> 42.0
2. Solid organ or hematologic transplant, or currently being evaluated for a transplant
3. Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
4. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
5. 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
6. Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
7. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
8. Active systemic infection
9. COVID-19 disease
i. Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date j. Uncontrolled diabetes mellitus or a recorded HgbA1c \> 8.0% in the 90 days prior to the Consent Date k. Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (\>30 pauses per hour) l. Medication Use: Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
10. Predicted life expectancy less than one (1) year
11. 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
12. 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
13. Contraindication to ICM insertion: Patients who cannot tolerate a subcutaneous, chronically-inserted LUX-Dx device
14. LUX-Dx longevity: Patients with a LUX-Dx device inserted \> 6 months prior to enrollment with an estimated longevity of less than 1 year
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Vivek Reddy
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Grandview Medical Center-Hospital
Birmingham, Alabama, United States
Banner University Medical Center Phoenix-Hospital
Phoenix, Arizona, United States
Arrhythmia Research Group-Research Facility
Jonesboro, Arkansas, United States
Scripps Memorial Hospital-Hospital
La Jolla, California, United States
Cedars - Sinai Medical Center-Hospital
Los Angeles, California, United States
University of California, San Francisco-Hospital
San Francisco, California, United States
Emory University Hospital-Hospital
Atlanta, Georgia, United States
St. Lukes Idaho Cardiology Associates-Hospital
Boise, Idaho, United States
Northwestern University-Hospital
Evanston, Illinois, United States
St. John's Hospital-Hospital
Springfield, Illinois, United States
St. Vincent's Hospital-Hospital
Indianapolis, Indiana, United States
Mercy Hospital Medical Center-Hospital
West Des Moines, Iowa, United States
University of Kansas Hospital-Hospital
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Johns Hopkins Hospital - East Baltimore Campus
Baltimore, Maryland, United States
Massachusetts General Hospital-Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital-Hospital
Boston, Massachusetts, United States
Lahey Clinic Hospital-Hospital
Burlington, Massachusetts, United States
St. Luke's Hospital of Kansas City-Hospital
Kansas City, Missouri, United States
Catholic Medical Center-Hospital
Manchester, New Hampshire, United States
Valley Hospital-Hospital
Ridgewood, New Jersey, United States
NYU Langone Health Heart Rhythm Center
New York, New York, United States
Weill Cornell Medical University-Hospital
New York, New York, United States
Mount Sinai Medical Center-Hospital
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
St. Francis Hospital-Hospital
Roslyn, New York, United States
Bethesda North Hospital-Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation-Hospital
Cleveland, Ohio, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital-Hospital
Columbus, Ohio, United States
Doylestown Hospital-Hospital
Doylestown, Pennsylvania, United States
UPMC Heart and Vascular Institute Harrisburg
Harrisburg, Pennsylvania, United States
Hospital of the University of Pennsylvania-Hospital
Philadelphia, Pennsylvania, United States
Trident Medical Center-Hospital
Charleston, South Carolina, United States
St. Thomas Research Institute, LLC-Hospital
Nashville, Tennessee, United States
Vanderbilt University Medical Center-Hospital
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research-Hospital
Austin, Texas, United States
Orion Medical - Gulf Commerce Drive
Houston, Texas, United States
Christus Trinity Mother Frances Health System-Hospital
Tyler, Texas, United States
Sentara Norfolk General Hospital-Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Health System-Hospital
Richmond, Virginia, United States
UZ Brussel (AZ VUB)-Hospital
Brussels, , Belgium
McGill University Health Centre-Hospital
Montreal, Quebec, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec-Hospital
Ste-Foy, Quebec, Canada
Clinica Universidad de Navarra-Hospital
Pamplona, , Spain
Countries
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References
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Matsumoto K, van Bragt KA, Kueffer FJ, Mburu W, Tarakji KG. Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation. J Interv Card Electrophysiol. 2025 Sep 10. doi: 10.1007/s10840-025-02124-6. Online ahead of print.
Reddy VY, Gerstenfeld EP, Schmidt B, Nair D, Natale A, Saliba W, Verma A, Sommer P, Metzner A, Turagam M, Weiner S, Champagne J, Garcio-Bolao I, Calkins H, Olson J, Issa Z, Winner M, Su W, Tomassoni G, Kim J, Hook B, Delurgio DB, Gibson DN, Daccarett M, Patel C, Bhalla K, Shehata M, Harding JD, Cheung JW, Raybuck JD, Roelke S, Schwartz T, Sutton BS, Mansour M; ADVANTAGE-AF Investigators. Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF. J Am Coll Cardiol. 2025 May 6;85(17):1664-1678. doi: 10.1016/j.jacc.2025.03.515.
Reddy VY, Gerstenfeld EP, Schmidt B, Andrade JG, Nair D, Natale A, Saliba W, Sommer P, Metzner A, Verma A, Hounshell T, Amin A, Gentlesk P, Weiner S, Cuoco FA, Kim J, Turagam MK, Tomassoni G, Patel C, Issa Z, Shehata M, Anderson AM, Stoltz TJ, Raybuck JD, Schwartz T, Sutton BS, Mansour M; ADVANTAGE AF Investigators. Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous Electrocardiographic Monitoring Follow-Up: ADVANTAGE AF Phase 2. Circulation. 2025 Jul 8;152(1):27-40. doi: 10.1161/CIRCULATIONAHA.125.074485. Epub 2025 Apr 24.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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92836802
Identifier Type: -
Identifier Source: org_study_id