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Persistent Atrial FibrillationADVANTAGE AFNCT05443594

A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation

A study testing Phase 1: FARAPULSE Ablation System and Phase 2: FARAPULSE Ablation System in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 44 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
Phase 1: FARAPULSE Ablation System and Phase 2: FARAPULSE Ablation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
669 participants
Where
44 sitesin 4 countries
Study dates
28 Feb 2023to 11 Feb 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age ≥ 18 years of age, or older if specified by local law
  • Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as:
  • 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).
  • Persistent: continuous AF for > 7 days and ≤ 365 days
  • Subjects who are willing and capable of providing informed consent
  • Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
Show all 12Show fewer
  • Age ≥ 18 years of age, or older if specified by local law
  • Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as:
  • 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).
  • Persistent: continuous AF for > 7 days and ≤ 365 days
  • Subjects who are willing and capable of providing informed consent
  • Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center

Who cannot join

  • Any of the following atrial conditions:
  • 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)
  • Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided SVT
  • Current atrial myxoma
  • Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
  • Current left atrial thrombus
Show all 88Show fewer
  • Cardiovascular exclusions - Any of the following CV conditions:
  • 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
  • Any of the following conditions at baseline (Section7.5):
  • Heart failure associated with NYHA Class III or IV
  • LVEF < 40%
  • Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment
  • Any of the following events within 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 non-neurologic thromboembolic event
  • Carotid stenting or endarterectomy
  • Thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis
  • Contraindication to, or unwillingness to use, systemic anticoagulation
  • Patients who have not been on anticoagulation therapy for at least 4 weeks prior to the ablation procedure
  • 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
  • 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:
  • Body Mass Index (BMI) > 42.0
  • Solid organ or hematologic transplant, or currently being evaluated for a transplant
  • Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
  • Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
  • 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
  • Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or 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
  • Active systemic infection
  • COVID-19 disease
  • 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)
  • Predicted life expectancy less than one (1) year
  • 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] --------------------------------------------
  • Any of the following atrial conditions:
  • 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)
  • Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided SVT
  • Current atrial myxoma
  • Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
  • Current left atrial thrombus
  • Cardiovascular exclusions - Any of the following CV conditions:
  • History of sustained ventricular tachycardia or any ventricular fibrillation
  • AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
  • 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
  • Valvular disease that is any of the following:
  • 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
  • Any of the following conditions at baseline (Section7.5):
  • Heart failure associated with NYHA Class III or IV
  • LVEF < 40%
  • Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment
  • Ventricular dysfunction: Right ventricular dysfunction
  • Any of the following events within 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 non-neurologic thromboembolic event
  • Carotid stenting or endarterectomy
  • Thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis
  • Contraindication to, or unwillingness to use, systemic anticoagulation
  • Patients who have not been on anticoagulation therapy for at least 4 weeks prior to the ablation procedure
  • 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
  • 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:
  • Body Mass Index (BMI) > 42.0
  • Solid organ or hematologic transplant, or currently being evaluated for a transplant
  • Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
  • Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
  • 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
  • Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or 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
  • Active systemic infection
  • COVID-19 disease
  • 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
  • Predicted life expectancy less than one (1) year
  • 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
  • Any of the following congenital conditions:
  • Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
  • Methemoglobinemia: History of known congenital methemoglobinemia
  • G6PD deficiency: History of known G6PD deficiency
  • Contraindication to ICM insertion: Patients who cannot tolerate a subcutaneous, chronically-inserted LUX-Dx device
  • LUX-Dx longevity: Patients with a LUX-Dx device inserted > 6 months prior to enrollment with an estimated longevity of less than 1 year

Trial locations and contacts

44 sites in 4 countries.

44 sites in 4 countries

United States40 sites

  • Emory University Hospital-Hospital

    Atlanta, Georgia, 30322

  • Texas Cardiac Arrhythmia Research-Hospital

    Austin, Texas, 78705

  • Johns Hopkins Hospital - East Baltimore Campus

    Baltimore, Maryland, 21287

  • Grandview Medical Center-Hospital

    Birmingham, Alabama, 35243

  • St. Lukes Idaho Cardiology Associates-Hospital

    Boise, Idaho, 83712

  • Massachusetts General Hospital-Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital-Hospital

    Boston, Massachusetts, 02115

  • Lahey Clinic Hospital-Hospital

    Burlington, Massachusetts, 01805

  • Trident Medical Center-Hospital

    Charleston, South Carolina, 29406

  • Bethesda North Hospital-Hospital

    Cincinnati, Ohio, 45242

  • Cleveland Clinic Foundation-Hospital

    Cleveland, Ohio, 44195

  • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital-Hospital

    Columbus, Ohio, 43214

  • Doylestown Hospital-Hospital

    Doylestown, Pennsylvania, 18901

  • Northwestern University-Hospital

    Evanston, Illinois, 60208

  • UPMC Heart and Vascular Institute Harrisburg

    Harrisburg, Pennsylvania, 17101

  • Orion Medical - Gulf Commerce Drive

    Houston, Texas, 77034

  • St. Vincent's Hospital-Hospital

    Indianapolis, Indiana, 46260

  • Arrhythmia Research Group-Research Facility

    Jonesboro, Arkansas, 72401

  • University of Kansas Hospital-Hospital

    Kansas City, Kansas, 66160

  • St. Luke's Hospital of Kansas City-Hospital

    Kansas City, Missouri, 64111

  • Scripps Memorial Hospital-Hospital

    La Jolla, California, 92037

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Cedars - Sinai Medical Center-Hospital

    Los Angeles, California, 90048

  • Catholic Medical Center-Hospital

    Manchester, New Hampshire, 03102

  • St. Thomas Research Institute, LLC-Hospital

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center-Hospital

    Nashville, Tennessee, 37232

  • NYU Langone Health Heart Rhythm Center

    New York, New York, 10016

  • Weill Cornell Medical University-Hospital

    New York, New York, 10021

  • Mount Sinai Medical Center-Hospital

    New York, New York, 10029

  • Lenox Hill Hospital

    New York, New York, 10075

  • Sentara Norfolk General Hospital-Hospital

    Norfolk, Virginia, 23507

  • Hospital of the University of Pennsylvania-Hospital

    Philadelphia, Pennsylvania, 19104

  • Banner University Medical Center Phoenix-Hospital

    Phoenix, Arizona, 85006

  • Virginia Commonwealth University Health System-Hospital

    Richmond, Virginia, 23219

  • Valley Hospital-Hospital

    Ridgewood, New Jersey, 07450

  • St. Francis Hospital-Hospital

    Roslyn, New York, 11576

  • University of California, San Francisco-Hospital

    San Francisco, California, 94143-0112

  • St. John's Hospital-Hospital

    Springfield, Illinois, 62769

  • Christus Trinity Mother Frances Health System-Hospital

    Tyler, Texas, 75701

  • Mercy Hospital Medical Center-Hospital

    West Des Moines, Iowa, 50266

Other trials in United States

Canada2 sites

  • McGill University Health Centre-Hospital

    Montreal, Quebec, H3G 1A4

  • Institut universitaire de Cardiologie et de Pneumologie de Quebec-Hospital

    Ste-Foy, Quebec, G1V 4G5

Other trials in Canada

Belgium1 site

  • UZ Brussel (AZ VUB)-Hospital

    Brussels, 1090

Other trials in Belgium

Spain1 site

  • Clinica Universidad de Navarra-Hospital

    Pamplona, 31008

Other trials in Spain

About this study

The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).

Being tested
Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • Phase 1: FARAPULSE Ablation SystemDevice

    PHASE 1: Pulsed Field Ablation to isolate the Pulmonary Veins and Posterior Wall using the FARAPULSE Ablation System.

  • Phase 2: FARAPULSE Ablation SystemDevice

    PHASE 2: Pulsed Field Ablation to isolate the Pulmonary Veins, Posterior Wall and Cavo-Tricuspid Isthmus using the FARAPULSE Ablation System.

Study groups in NCT05443594
Study groupRoleWhat they receive
Pulsed Field Ablation (Phase 1)ExperimentalPHASE 1 only
Receives: Device: Phase 1: FARAPULSE Ablation System
Pulsed Field Ablation (Phase 2)ExperimentalPHASE 2 only
Receives: Device: Phase 2: FARAPULSE Ablation System

What is being measured

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

  1. Primary Safety Endpoint (PSE): Event Rate of Safety Events Post Procedure

    Phase 1:

    Through 7 Days:

    • Myocardial infarction
    • Stroke
    • Transient Ischemic Attack (TIA)
    • Peripheral or organ thromboembolism
    • Pulmonary edema
    • Unresolved phrenic nerve palsy / paresis
    • Vascular access complications
    • Heart block
    • Gastric motility / pyloric spasm disorders

    Through 30 Days:

    • Cardiac tamponade / perforation
    • Pericarditis

    Through 360 Days Post-Procedure:

    • PV stenosis
    • Atrio-esophageal fistula

    Phase 2

    Through 7 Days:

    • Myocardial infarction
    • Stroke
    • Transient Ischemic Attack (TIA)
    • Peripheral or organ thromboembolism
    • Pulmonary edema
    • Unresolved phrenic nerve palsy / paresis
    • Vascular access complications
    • Heart block
    • Gastric motility / pyloric spasm disorders

    Through 30 Days:

    • Death
    • Cardiac tamponade / perforation
    • Pericarditis
    • Any PFA system related PFA procedure-related cardiovascular or pulmonary adverse event

    Through 90 Days:

    • PV stenosis
    • Atrio-esophageal fistula

    Measured: Phase 1 Index Procedure through 360 Days | Phase 2 Index Procedure through 90 Days (per protocol Primary Safety Endpoint requirements)

  2. Primary Effectiveness Endpoint: Treatment Success Rate Through Day 360

    Includes both Acute Procedural Success and Chronic Success through Day 360.

    Measured: Post-Blanking Period: Day 90 through Day 360

Timeline

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

  1. First posted5 Jul 2022
  2. Study start28 Feb 2023
  3. Primary completion11 Feb 2025
  4. Study completion11 Feb 2025

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
669 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443594
Sponsor's protocol ID
92836802
Acronym
ADVANTAGE AF
Status last verified
Nov 2025
First submitted
29 Jun 2022
Last updated
16 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Gerstenfeld EP, Schmidt B, Natale A, Nair D, Saliba W, Verma A, Sommer P, Metzner A, Dewland TA, Moss JD, Amin A, Champagne J, Cuoco F, Hounshell T, Issa Z, Turagam M, Brose R, Schwartz T, Raybuck JD, Garlitski A, Mansour M, Reddy VY. Pulsed Field Ablation vs Standard Radiofrequency Ablation for Typical Atrial Flutter: ADVANTAGE AF Trial Substudy. J Am Coll Cardiol. 2026 Apr 14;87(14):1764-1778. doi: 10.1016/j.jacc.2025.12.081. Epub 2026 Feb 6.

    PubMed 41653174

  • 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. 2026 Apr;69(3):355-363. doi: 10.1007/s10840-025-02124-6. Epub 2025 Sep 10.

    PubMed 40928625

  • 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.

    PubMed 40306839

  • 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.

    PubMed 40273320

Questions about this trial

What is this clinical trial studying?

A study testing Phase 1: FARAPULSE Ablation System and Phase 2: FARAPULSE Ablation System in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 44 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 12 inclusion and 88 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: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Canada, Belgium, 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?

Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (PSE): Event Rate of Safety Events Post Procedure (time frame: Phase 1 Index Procedure through 360 Days | Phase 2 Index Procedure through 90 Days (per protocol Primary Safety Endpoint requirements)). 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 NCT05443594, which also lists 4 linked publications.

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 16 Dec 2025.

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