Paroxysmal Atrial Fibrillation (PAF)FARADIGMNCT07575269
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
A study testing FARAFLEX Mapping and Pulsed Field Ablation (PFA) System in people with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 13 sites in 4 countries.
Trial summary
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
- What is being tested?
- FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 571 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 7 Jul 2026to 1 Jan 2030
- Phase
- Interventional
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
- At least 18 years old (or older if required by local law)
- Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).
- Willing and capable of providing written informed consent
- Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site
Who cannot join
- Any of the following atrial conditions:
- Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL
- Any prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)
- Any prior atrial surgery
- Current atrial myxoma
- Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)
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- Current left atrial thrombus
- Any of the following cardiovascular conditions:
- History of sustained ventricular tachycardia or ventricular fibrillation
- Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)
- Presence of any of the following cardiac devices or implants:
- Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device
- Current implantable loop recorder other than LUX-Dx
- Prior interatrial baffle or septal closure device/patch (Patent Foramen Ovale (PFO)or Atrial Septal Defect (ASD))
- Left atrial appendage closure or occlusion device
- Clinically significant valvular disease, including:
- Any cardiac valve prosthesis, ring, repair, or clip
- Moderate to severe mitral stenosis
- Moderate to severe aortic stenosis
- Severe mitral regurgitation
- Severe tricuspid regurgitation
- Hypertrophic or amyloid cardiomyopathy
- Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access
- Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure/occlusion procedures allowed no less than (≥) 60 days after index procedure)
- Severe right ventricular dysfunction per investigator assessment
- Any of the following congenital conditions:
- Congenital heart disease with clinically significant residual anatomic or conduction abnormalities, or channelopathies
- Known congenital methemoglobinemia
- Known G6PD deficiency
- Any of the following medical history conditions:
- Solid organ or hematologic transplant, or under evaluation for transplant
- History or current evidence of hemi-diaphragmatic paralysis or paresis
- Prinzmetal angina or severe non-revascularizable coronary disease
- Known coagulopathy or bleeding disorder
- Renal insufficiency, history of dialysis, or renal transplant
- Known allergic reaction to nitroglycerin (excluding hypotension)
- Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
- Active spinal cord stimulator
- Any of the following baseline conditions:
- NYHA Class III or IV heart failure
- Left ventricular ejection fraction (LVEF) less than 40% within 12 months
- CHA2DS2-VASc score greater than or equal to 5
- Body mass index (BMI) greater than 45.0
- Contraindication to or unwillingness to use systemic anticoagulation peri-procedurally
- Pregnant or lactating at time of procedure
- Severe lung disease, pulmonary hypertension, or oxygen-dependent lung disease
- Active malignancy (excluding squamous cell carcinoma)
- Clinically significant gastrointestinal disease (e.g., severe or erosive esophagitis, uncontrolled reflux, gastroparesis, esophageal candidiasis, active gastroduodenal ulceration)
- Known Active systemic infection
- Life expectancy of less than 1 year
- Concurrent enrollment in another investigational study or registry that may interfere with this study (exceptions include mandatory governmental registries or purely observational registries with sponsor approval)
- Any of the following events within 90 days prior to consent:
- Myocardial infarction, unstable angina, or coronary intervention
- Pericarditis or symptomatic pericardial effusion
- Gastrointestinal bleeding
- Cardiac surgery
- Stroke, Transient Ischemic Attack (TIA), or intracranial bleeding
- Any active non-neurologic thrombus and/or thromboembolic event
- Carotid stenting or endarterectomy
- Heart failure hospitalization
- Uncontrolled diabetes mellitus or HbA1c greater than 8.0%
- Other conditions:
- Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted ICM from the LUX-Dx family of devices
- Any medical condition that, in the investigator's opinion, would interfere with study participation, increase risk, or affect data interpretation
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Sara Veraghtert contact
13 sites in 4 countries
United States10 sites, 10 recruiting
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Cynthia Barnes, cynthia.barnes@emory.edu
David DeLurgio
- Recruiting
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
Deb Cardinal, dscardinal@austinheartbeat.com
Andrea Natale, MD
- Recruiting
Massachusetts General Hospital-Hospital
Boston, Massachusetts, 02114
Peter Fox, pfox6@mgh.harvard.edu
Moussa Mansour
- Recruiting
Trident Medical Center
Charleston, South Carolina, 29406
Anthony Awkar, anthony.awkar@hcahealthcare.com
Frank Cuoco
- Recruiting
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, 43214
Steven Neville, Steven.Neville@ohiohealth.com
Auroa Badin
- Recruiting
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Tiffany Warhurst, twarhurst@dnairresearch.com
Devi Nair
- Recruiting
Pinnacle Health at Harrisburg Hospital - UPMC Pinnacle
Mechanicsburg, Pennsylvania, 17050
Misty Schively, schivelymm3@upmc.edu
Patel Chinmay
- Recruiting
Mount Sinai Medical Center-Hospital
New York, New York, 10029
Jeff Lam, jeff.lam@icahn.mssm.edu
Mohit Turagam
- Recruiting
Christus Trinity Mother Frances Health System-Hospital
Tyler, Texas, 75701
Adrian Maples, adrian.maples@christushealth.org
Stanislav Weiner
- Recruiting
Mercy Hospital Medical Center
West Des Moines, Iowa, 50266
Natasha Mairs, natasha.mairs@mercyone.org
Troy Hounshell
Belgium1 site, 1 recruiting
- Recruiting
St. Jan-Hospital
Bruges, B-8000
Steffie Vanslambrouck, steffie.vanslambrouck@azsintjan.be
Mattias Duytschaever
Ireland1 site, 1 recruiting
- Recruiting
Mater Private Hospital-Hospital
Dublin, Dublin, D07 RD8P
Kristine Laurilla, kristine.laurilla@materprivate.ie
Garbor Szeplaki
Spain1 site, 1 recruiting
- Recruiting
Clínica Universidad de Navarra
Pamplona, 31008
Pilar Ara Lucea, pilarara@unav.es
Jose Ignacio Garcia Bolao
About this study
Official title: Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation - A Global Prospective Single Arm Study
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is:
Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients?
Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.
- Being tested
- FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
- Keywords
- pulsed field ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAFLEX Mapping and Pulsed Field Ablation (PFA) SystemDevice
Also called FARAFLEX Mapping and Pulsed Field Ablation (PFA) Catheter, FARAFLEX Catheter
Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| FARAFLEX Mapping and Pulsed Field Ablation (PFA) System | Experimental | Participants undergo a catheter procedure using the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System to treat atrial fibrillation. The catheter is used to map the heart's electrical signals and deliver pulsed field ablation therapy. Receives: Device: FARAFLEX Mapping and Pulsed Field Ablation (PFA) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure.
Occurrence of defined Composite Serious Adverse Events after the procedure through Day 60.
Measured: After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60
The primary effectiveness endpoint (PEE) is the proportion of Treatment Subjects with Treatment Success through the Day 365 Assessment.
Acute Procedural Success defined as Pulmonary Vein (PV) Isolation and Chronic Success. Chronic Success is defined as freedom from the following after the Blanking Period (60 days):
- Arrhythmia: Occurrence of any Detectable Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT)
- Re-ablation: Any re-ablation for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT)
- Cardioversion: Any electrical cardioversion for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT)
- Antiarrhythmic Drug (AAD) Use: dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new AAD.
Measured: Day 0 through the Day 365 Assessment
Secondary outcomes (2)
Atrial Arrhythmia Burden Success Endpoint
Atrial Arrhythmia Burden Success is defined as the proportion of Treatment subjects with atrial arrhythmia burden less than or equal to 0.1% in the time period post-blanking period through 6 months, as measured by LUX-Dx.
Measured: Post-blanking period (Day 60) through 6 months (Day 180)
Cavo-Tricuspid Isthmus (CTI) Ablation - Acute Procedural Endpoint
Defined as the proportion of Treatment Subjects who underwent a Cavo-Tricuspid Isthmus (CTI) ablation during the Index Procedure, regardless of the atrial fibrillation cohort, with absence of conduction through the cavo-tricuspid isthmus in both directions (bidirectional block), achieved with the FARAFLEX™ Mapping and PFA Catheter only, and confirmed prior to the end of the Index Ablation Procedure.
Measured: Index Ablation Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start7 Jul 2026
- Primary completion20 Jul 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 571 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575269
- Sponsor's protocol ID
- PF314
- Acronym
- FARADIGM
- Status last verified
- Oct 2026
- First submitted
- 4 May 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes