Atrial Fibrillation (AF)ReDEFINE-AFNCT07820930
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
A study testing FARAFLEX Mapping and Pulsed Field Ablation System in people with Atrial Fibrillation (AF) and Persistent Atrial Fibrillation (PersAF), run by Boston Scientific Corporation.
Trial summary
The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF), Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- FARAFLEX Mapping and Pulsed Field Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
- Subjects with symptomatic atrial fibrillation who have documented Persistent Atrial Fibrillation (PersAD) or Paroxysmal Atrial Fibrillation (PAF) with at least one documented symptomatic AF episode lasting at least 24 hours.
- AND Undergone one failed endocardial atrial fibrillation ablation procedure OR undergone no more than two prior endocardial atrial fibrillation ablation procedures that were both limited to PV and/or PW ablation.
- Willing and capable of providing informed consent.
- Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center.
- Willing to receive a LUX-Dx insertable cardiac monitor (ICM) during the study or already has a LUX-Dx ICM that was inserted within 6 months prior to consent, and willing to comply with the LUX-Dx Latitude Clarity transmission instructions.
Who cannot join
- Any of the following atrial conditions:
- Left atrial anteroposterior (LA) diameter ≥ 6.5 cm, or if LA diameter is not available, non-indexed LA volume >100 mL.
- Current atrial myxoma.
- Current left atrial thrombus.
- Any PV abnormality, stenosis, or stenting. Common and middle PVs are admissible.
- Any of the following cardiovascular conditions:
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- History of sustained ventricular tachycardia or any ventricular fibrillation.
- Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
- Atrial Fibrillation (AF) that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
- Presence of any of the following:
- Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device.
- Implantable loop recorder other than a LUX-Dx device
- Interatrial baffle, atrial septal defect or patent foramen ovale closure device or patch
- Left Atrial Appendage Closure or Occlusion Device
- Presence of any of the following:
- Any cardiac valve prosthesis, ring, repair, or clip.
- Mitral valve stenosis: moderate or greater.
- Aortic stenosis: moderate or greater.
- Severe mitral regurgitation.
- Severe tricuspid regurgitation.
- Hypertrophic or amyloid cardiomyopathy.
- Any IVC filter, known inability to obtain vascular access, or other contraindication to femoral access.
- Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months.
- Any of the following conditions documented during eligibility assessment or Baseline Assessment, as applicable:
- Heart failure associated with NYHA Class III or IV, as documented during eligibility assessment or Baseline Assessment.
- Most recent documented LVEF <40% within the previous 12 months.
- Body Mass Index (BMI) >45.0 kg/m², as documented during eligibility assessment or Baseline Assessment.
- Known coagulopathy or bleeding disorder.
- Contraindication to, or unwillingness to use, systemic anticoagulation or acceptable alternatives pre-, intra-, and post-procedure to achieve adequate anticoagulation.
- Women who are confirmed to be pregnant or lactating at the time of the ablation procedure.
- Severe lung disease, including but not limited to severe pulmonary hypertension, involving abnormal blood gases or requiring supplemental oxygen.
- Active malignancy other than squamous cell carcinoma.
- Clinically significant gastrointestinal problems involving the esophagus or stomach, including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis, or active gastroduodenal ulceration.
- Known active systemic infection.
- Predicted life expectancy of less than one year per Investigator medical judgment.
- 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.
- Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure.
- Known allergic drug reaction to nitroglycerin, excluding hypotension.
- Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device.
- Presence of an active spinal cord stimulator.
- Any of the following congenital conditions:
- Congenital heart disease with any clinically significant residual anatomic or conduction abnormality.
- History of known congenital methemoglobinemia.
- History of known G6PD deficiency.
- Any of the following conditions in the medical history:
- Solid organ or hematologic transplant, or currently being evaluated for a transplant.
- Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
- Any documented history of Prinzmetal angina or severe non-revascularizable coronary disease.
- Renal insufficiency if an estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73 m², or any history of renal dialysis or renal transplant.
- Any other general health condition 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.
- Any of the following events within 90 days prior of the consent date:
- Myocardial infarction, unstable angina, or coronary intervention.
- Any cardiac surgery.
- Heart failure hospitalization.
- Pericarditis or symptomatic pericardial effusion.
- Gastrointestinal bleeding.
- Stroke, TIA, or intracranial bleeding.
- Any active non-neurologic thrombus and/or thromboembolic event.
- Carotid stenting or endarterectomy.
- Uncontrolled diabetes mellitus or a recorded HbA1c >8.0%.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF), Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- FARAFLEX Mapping and Pulsed Field Ablation System
- Keywords
- Pulsed Field Ablation, Electrographic Flow Mapping, FARAFLEX, OptiMap, Catheter Ablation, EGF, Repeat Ablation, Pulmonary Vein Isolation, Posterior Wall Ablation, ICM
- 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 SystemDevice
Catheter used for electrophysiological mapping of cardiac structures and the treatment of paroxysmal or persistent atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects will undergo EGF mapping using the OptiMap™ Catheter and System, followed by ablation of eligible EGF-identified extra-pulmonary vein sources using the FARAFLEX™ Mapping and PFA System. Receives: Device: FARAFLEX Mapping and Pulsed Field Ablation System |
| Control Arm | Active comparator | Subjects will undergo EGF mapping using the OptiMap™ Catheter and System. For Control Arm subjects who have not previously undergone posterior wall ablation/isolation and who do not have documented durable posterior wall isolation, protocol-defined de novo posterior wall ablation will be performed using the FARAFLEX™ Mapping and PFA System. Receives: Device: FARAFLEX Mapping and Pulsed Field Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Effectiveness Endpoint (PEE) is the Proportion of Randomized Subjects in the Main Study Cohort achieving Treatment Success through the Day 365 Assessment.
The Primary Effectiveness Endpoint analysis will compare Treatment Success between the Treatment Arm and the Control Arm in randomized subjects in the Main Study Cohort.
Measured: Day 180 through Day 365 Assessment
Secondary outcomes (1)
The Secondary Safety Endpoint is the rate of protocol-defined device- or procedure-related Composite Serious Adverse Events (CSAE).
The secondary safety endpoint will be evaluated in Randomized Treatment Arm subjects and will not contribute to study success criteria.
Measured: Day 0 through Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820930
- Sponsor's protocol ID
- PF340
- Acronym
- ReDEFINE-AF
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07820930
- Acronym / sponsor ID
- ReDEFINE-AF / PF340
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF), Paroxysmal Atrial Fibrillation (PAF)
- Keywords
- Pulsed Field Ablation, Electrographic Flow Mapping, FARAFLEX, OptiMap, Catheter Ablation, EGF, Repeat Ablation, Pulmonary Vein Isolation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial fibrillation (AF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: FARAFLEX Mapping and Pulsed Field Ablation SystemSubjects will undergo EGF mapping using the OptiMap™ Catheter and System, followed by ablation of eligible EGF-identified extra-pulmonary vein sources using the FARAFLEX™ Mapping and PFA System. |
| Control Arm | Active comparator | Device: FARAFLEX Mapping and Pulsed Field Ablation SystemSubjects will undergo EGF mapping using the OptiMap™ Catheter and System. For Control Arm subjects who have not previously undergone posterior wall ablation/isolation and who do not have documented durable posterior wall isolation, protocol-defined de novo posterior wall ablation will be performed using the FARAFLEX™ Mapping and PFA System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years old, or older if required by local law.
- Subjects with symptomatic atrial fibrillation who have documented Persistent Atrial Fibrillation (PersAD) or Paroxysmal Atrial Fibrillation (PAF) with at least one documented symptomatic AF episode lasting at least 24 hours.
- AND Undergone one failed endocardial atrial fibrillation ablation procedure OR undergone no more than two prior endocardial atrial fibrillation ablation procedures that were both limited to PV and/or PW ablation.
- Willing and capable of providing informed consent.
- Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center.
Key exclusion criteria (60 listed)
- Any of the following atrial conditions:
- Any of the following cardiovascular conditions:
- Any of the following conditions documented during eligibility assessment or Baseline Assessment, as applicable:
- Any of the following congenital conditions:
- Any of the following conditions in the medical history:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FARAFLEX Mapping and Pulsed Field Ablation SystemCatheter used for electrophysiological mapping of cardiac structures and the treatment of paroxysmal or persistent atrial fibrillation. | Device | Control Arm, Treatment Arm |
Primary outcome
The Primary Effectiveness Endpoint (PEE) is the Proportion of Randomized Subjects in the Main Study Cohort achieving Treatment Success through the Day 365 Assessment.
Time frame: Day 180 through Day 365 Assessment
The Primary Effectiveness Endpoint analysis will compare Treatment Success between the Treatment Arm and the Control Arm in randomized subjects in the Main Study Cohort.
1 secondary outcome
The Secondary Safety Endpoint is the rate of protocol-defined device- or procedure-related Composite Serious Adverse Events (CSAE).
Time frame: Day 0 through Day 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing FARAFLEX Mapping and Pulsed Field Ablation System in people with Atrial Fibrillation (AF) and Persistent Atrial Fibrillation (PersAF), run by Boston Scientific Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 60 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliza Lawrence ((650) 215-1267, Eliza.Lawrence@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Effectiveness Endpoint (PEE) is the Proportion of Randomized Subjects in the Main Study Cohort achieving Treatment Success through the Day 365 Assessment. (time frame: Day 180 through Day 365 Assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.