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Atrial Fibrillation (AF)OPTIMIZENCT07187115

A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation

A study testing FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative) and FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System in people with Atrial Fibrillation (AF) and Persistant Atrial Fibrillation, run by Boston Scientific Corporation at 15 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative) and FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
699 participants
Where
15 sitesin 4 countries
Study dates
7 Nov 2025to Jan 2027
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

  • ≥ 18 years of age, or older if required by local law
  • Have symptomatic drug-refractory1, persistent AF2, confirmed by both:
  • Documentation, such as physician note, of persistent continuous AF for > 7 days and ≤ 365 days and the arrhythmia symptoms
  • Documentation, within 180 days of enrollment date of either:
  • A 24-hour continuous ECG recording confirming continuous AF or
  • Two (2) ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart
Show all 9Show fewer
  • 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 LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months (i.e., within 180 days) of consent, and willing to comply to the LUX-Dx Latitude Clarity transmission instructions

Who cannot join

  • Any of the following atrial conditions:
  • Left atrial anteroposterior diameter ≥ 5.5 cm, or if1 LA diameter not available, non-indexed volume >100 ml (physician note or imaging)
  • Any prior left atrial ablation
  • Any prior atrial surgery
  • Current atrial myxoma
  • Current left atrial thrombus
Show all 63Show fewer
  • Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
  • Any of the following cardiovascular conditions:
  • History of sustained ventricular tachycardia or any ventricular fibrillation
  • Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data, per Investigator's discretion
  • AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
  • Cardiac devices and implants:
  • Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
  • Implantable loop recorder, other than LUX-Dx
  • Interatrial baffle, patent foramen ovale or atrial septal defect closure device or patch
  • Any left atrial appendage closure or occlusion device
  • Presence of any of the following valvular conditions:
  • Any prosthetic heart valve, stenotic valves, ring or repair
  • Moderate to severe mitral valve stenosis
  • More than moderate mitral 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
  • Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
  • Any of the following conditions at Baseline:
  • Heart failure associated with NYHA Class III or IV
  • Most recent documented LVEF < 40% within the previous 12 months
  • Body Mass Index (BMI) > 45.0
  • 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, severe pulmonary hypertension, or any lung disease 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
  • Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (>30 pauses per hour) as per the guidelines
  • Predicted life expectancy less than one year per investigator medical judgement
  • 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
  • Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
  • Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion
  • CHA2DS2-VASc score ≥ 5
  • Known allergic drug reaction to nitroglycerin (excluding hypotension)
  • Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device
  • 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 with 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 less than or equal to 90 days of the consent date:
  • Myocardial infarction (MI), 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

15 sites in 4 countries.

15 sites in 4 countries

United States11 sites

  • Piedmont Athens Regional

    Athens, Georgia, 30606

  • Emory University Hospital

    Atlanta, Georgia, 30308

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • St. Luke's Boise Medical Center

    Boise, Idaho, 83702

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401

  • Mount Sinai Medical Center

    New York, New York, 10029

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Pacific Heart Institute

    Santa Monica, California, 90404

  • Christus Trinity Mother Frances Health System

    Tyler, Texas, 75701

Other trials in United States

Belgium2 sites

  • AZORG

    Aalst, 9300

  • Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

    Hasselt, 3500

Other trials in Belgium

Hong Kong1 site

  • Prince of Wales Hosptial

    Shatin, Hong Kong

Other trials in Hong Kong

Spain1 site

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: A Global Randomized Trial Comparing Pulsed Field Ablation of Pulmonary Veins Plus Extra-PV Sources Utilizing Electrographic Flow Mapping Versus Pulmonary Veins Plus Posterior Wall in Persistent Atrial Fibrillation Patients.

The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).

Being tested
FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative), FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
Keywords
FARAPULSE, FARAPOINT, OptiMap
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FARAPOINT Pulsed Field Ablation SystemDevice

    A component of the FARAPULSE Pulsed Field Ablation (PFA) System and is a multi-electrode bidirectional, deflectable percutaneous catheter, an adjunctive catheter designed to create focal-type lesions for the creation of an ablation line between the inferior vena cava and the tricuspid valve.

  • OptiMap System (non-ablative)Device

    Also called Ablamap System

    An electrophysiology mapping system that uses a proprietary algorithm to analyze electrogram signals.

  • FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping SystemDevice

    All subjects will undergo electroanatomical mapping of the entire left atrium with the FARAWAVE NAV Catheter and Opal HDx Mapping System, followed by PFA PVI with the FARAWAVE NAV PFA Catheter, per the instructions of use.

Study groups in NCT07187115
Study groupRoleWhat they receive
Control ArmActive comparatorPVI + PWA: The Control Arm, consisting of subjects undergoing PVI + PWA. PWA will be performed adjunctive to PVI per protocol Section 10.8.10. Following confirmation of PWA, EGF mapping will be performed in the LA and RA, while Investigators, lab/nursing staff, and research personnel are blinded to the EGF maps.
Receives: Device: OptiMap System (non-ablative); Device: FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
Treatment ArmExperimentalPVI + EGF source(s) ablation: The Treatment Arm, consisting of subjects undergoing PVI + EGF source(s) ablation. Adjunctive to PVI, the EGF-identified active sources above threshold will be ablated per protocol Section 10.8.11. If following PVI, a narrow channel that is approximately ≤ 1 cm is identified in the LAPW, ablation may be performed using the FARAPOINT Catheter.
Receives: Device: FARAPOINT Pulsed Field Ablation System; Device: OptiMap System (non-ablative); Device: FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint

    The primary safety endpoint is the rate of ITT subjects in the PVI+EGF arm with one or more of the following serious device- or procedure-related Composite Adverse Events (CAEs) assessed through 60 days following the Index Procedure.

    Measured: 60 Days

  2. Primary Effectiveness Endpoint

    The primary effectiveness endpoint is the rate of ITT subjects with treatment success in the PVI+EGF arm vs. the PVI+PWA control arm through Day 365, aiming to demonstrate non-inferiority of PVI+EGF compared to the PVI+PWA control.

    Measured: 365 Days

Secondary outcomes (1)

  1. Secondary Effectiveness Endpoint

    The secondary effectiveness endpoint is a test for superiority in Treatment Success between the Treatment Arm and the Control Arm. The test for superiority will only be conducted if the non-inferiority test for the PEE is passed and the result favors the Treatment Arm.

    Measured: 365 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start7 Nov 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Model description
plus non-randomized cohorts (Attempt, Roll-in)
Masking
None (open label)
Enrolment
699 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07187115
Sponsor's protocol ID
PF334
Acronym
OPTIMIZE
Status last verified
Oct 2026
First submitted
15 Sep 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative) and FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System in people with Atrial Fibrillation (AF) and Persistant Atrial Fibrillation, run by Boston Scientific Corporation at 15 sites in 4 countries.

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 9 inclusion and 63 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: under way, not looking for participants, 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.

Where is the study taking place?

The record lists 15 sites in United States, Belgium, Hong Kong, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint (time frame: 60 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07187115.

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.

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OPTIMIZE Clinical Trial NCT07187115 | AzTrials