Paroxysmal Atrial FibrillationSHINENCT03437733
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
A study testing Radiofrequency Ablation in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 5 sites in 3 countries.
Trial summary
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 28 Feb 2018to 17 Oct 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Symptomatic Paroxysmal AF.
- Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.
- Able and willing to comply with uninterrupted per-protocol anticoagulation requirements
- Age 18-75 years.
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
- Signed Patient Informed Consent Form.
Who cannot join
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous surgical or catheter ablation for AF.
- Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region
- Previously diagnosed with persistent, longstanding AF and/or continuous AF > 7 days, or > 48 hrs terminated by cardioversion.
- Any percutaneous coronary intervention (PCI) within the past 2 months.
- Valve repair or replacement and presence of a prosthetic valve.
Show all 38Show fewer
- Any carotid stenting or endarterectomy.
- Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.
- Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.
- LA antero posterior diameter > 50 mm
- Any PV with a diameter ≥ 26 mm
- Left Ventricular Ejection Fraction (LVEF) < 40%.
- Contraindication to anticoagulation (e.g. heparin).
- History of blood clotting or bleeding abnormalities.
- Myocardial infarction within the past 2 months.
- Documented thromboembolic event [including transient ischemic attack(TIA)] within the past 12 months.
- Rheumatic Heart Disease.
- Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- Unstable angina.
- Acute illness or active systemic infection or sepsis.
- Diagnosed atrial myxoma or interatrial baffle or patch.
- Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
- Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
- Enrollment in an investigational study evaluating another device, biologic, or drug.
- Has known pulmonary vein stenosis.
- Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
- Presence of an Inferior Vena Cava (IVC) filter
- Presence of a condition that precludes vascular access.
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
- Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use.
- Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being
- Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects:
- Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
- Presence of iron-containing metal fragments in the body
- Unresolved pre-existing neurological deficit.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom2 sites
Liverpool Heart and Chest Hospital
Liverpool
Bart's Health NHS Trust
London
About this study
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
Read the detailed description
The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Radiofrequency Ablation
- Keywords
- Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationDevice
RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter Receives: Device: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis
A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.
Measured: Up to 90 days (post initial mapping and ablation procedure)
Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding
A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.
Measured: Up to 7 days (post initial mapping and ablation procedure)
Percentage of Participants With Acute Procedural Success
Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).
Measured: Day 1
Secondary outcomes (14)
Number of Participants With Individual PAE From Primary Composite
A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included death, atrio-esophageal fistula (AE fistula) and pulmonary vein stenosis (PVST); and up to 90 days post procedure which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.
Measured: Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)
Number of Participants With Serious Adverse Device Effects (SADEs)
An adverse device effect is an adverse event related to the to the device and or the procedure of the investigational medical device. SADE is an adverse device effect that has resulted in any of the consequences characteristic of an SAE.
Measured: Up to 405 Days
Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure
Serious non-primary adverse event was defined as SAE that are not primary adverse events. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.
Measured: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
Number of Participants With Non-serious Adverse Events
An AE is any untoward medical occurrence in participants whether or not related to the investigational medical device.
Measured: Up to 405 Days
Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli
Number of participants with pre-and post-ablation asymptomatic and symptomatic cerebral emboli was reported.
Measured: Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)
Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli
Number of participants with symptomatic and asymptomatic cerebral emboli was reported
Measured: Up to 405 Days
Number of Participants With New or Worsening Neurologic Deficits
Number of participants with new or worsening neurologic deficits was reported.
Measured: Pre-procedure, discharge, 1 Month, 3 Month and 6 Month
Number of Participants With NIHSS Scores
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed to calculate a patient's total NIHSS score. The patient's total NIHSS score ranges from 0 (minimum) - 42 (maximum). Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke).
Measured: Pre-procedure and at discharge (Up to 405 Days)
Number of Participants With MoCA Scores
Montreal Cognitive Assessment (MoCA) is used for detecting cognitive impairment, the scores range from 0 to 30. A score of 26 or higher is considered normal, patients with mild cognitive impairment (MCI) were scored an average of 22 and patients with significant cognitive impairment (SCI) were scored an average of 16.
Measured: Up to 405 Days
Number of Participants With Hospitalization for Cardiovascular Events
Hospitalization was defined as prolonged stay greater than or equal to (>=) 2 nights post index procedure or in-patient stay not concurrent with index procedure >= 1 calendar day. Hospitalization included cardiovascular events due to any cause post index procedure, regardless of protocol-defined serious/non-serious adverse events (AEs) or not. Hence this data was not contributed in serious Adverse events until met the AE definition.
Measured: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants
Percentage of participants with PVI touch-up by balloon and/or focal catheter among all targeted veins and by participants was reported. Most of the participants were ablated by Balloon catheter only while one participant was ablated with both Balloon and Focal catheters.
Measured: Up to 405 Days
Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers
Percentage of participants with use of focal catheter ablation for non-PV triggers was reported.
Measured: Up to 405 Days
Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL
Percentage of participants with six-month arrythmia recurrence [defined as freedom from documented symptomatic or asymptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atypical (left side) atrial flutter (AFL) episodes (episodes >30 seconds on arrhythmia monitoring device from Day 91 to 180 post the index procedure)] was reported.
Measured: Up to 6 Months
Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL
Twelve-month Arrythmia recurrence is defined as a documented symptomatic or asymptomatic episode >30 seconds on an arrhythmia monitoring device between day 91 to 365 post the index procedure.
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start28 Feb 2018
- Primary completion1 Feb 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437733
- Sponsor's protocol ID
- BWI_2017_01
- Acronym
- SHINE
- Status last verified
- Jun 2025
- First submitted
- 13 Feb 2018
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Schilling R, Dhillon GS, Tondo C, Riva S, Grimaldi M, Quadrini F, Neuzil P, Chierchia GB, de Asmundis C, Abdelaal A, Vanderlinden L, Tan T, Ding WY, Gupta D, Reddy VY. Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace. 2021 Jun 7;23(6):851-860. doi: 10.1093/europace/euaa382.
PubMed 33450010
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
- ClinicalTrials.gov ID
- NCT03437733
- Acronym / sponsor ID
- SHINE / BWI_2017_01
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
Detailed description
The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Radiofrequency AblationAblation with Multi-electrode Radiofrequency (RF) Balloon Catheter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with Symptomatic Paroxysmal AF.
- Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.
- Able and willing to comply with uninterrupted per-protocol anticoagulation requirements
- Age 18-75 years.
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Key exclusion criteria (38 listed)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous surgical or catheter ablation for AF.
- Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region
- Previously diagnosed with persistent, longstanding AF and/or continuous AF > 7 days, or > 48 hrs terminated by cardioversion.
- Any percutaneous coronary intervention (PCI) within the past 2 months.
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 |
|---|---|---|
| Radiofrequency AblationRF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter | Device | Intervention |
Primary outcome
Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis
Time frame: Up to 90 days (post initial mapping and ablation procedure)
A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.
Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding
Time frame: Up to 7 days (post initial mapping and ablation procedure)
A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.
Percentage of Participants With Acute Procedural Success
Time frame: Day 1
Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).
14 secondary outcomes
Number of Participants With Individual PAE From Primary Composite
Time frame: Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)
Number of Participants With Serious Adverse Device Effects (SADEs)
Time frame: Up to 405 Days
Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure
Time frame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
Number of Participants With Non-serious Adverse Events
Time frame: Up to 405 Days
Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli
Time frame: Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)
Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli
Time frame: Up to 405 Days
Number of Participants With New or Worsening Neurologic Deficits
Time frame: Pre-procedure, discharge, 1 Month, 3 Month and 6 Month
Number of Participants With NIHSS Scores
Time frame: Pre-procedure and at discharge (Up to 405 Days)
Number of Participants With MoCA Scores
Time frame: Up to 405 Days
Number of Participants With Hospitalization for Cardiovascular Events
Time frame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants
Time frame: Up to 405 Days
Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers
Time frame: Up to 405 Days
Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL
Time frame: Up to 6 Months
Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL
Time frame: Up to 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33450010Schilling R, Dhillon GS, Tondo C, Riva S, Grimaldi M, Quadrini F, Neuzil P, Chierchia GB, de Asmundis C, Abdelaal A, Vanderlinden L, Tan T, Ding WY, Gupta D, Reddy VY. Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace. 2021 Jun 7;23(6):851-860. doi: 10.1093/europace/euaa382.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 5 sites in 3 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 6 inclusion and 38 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, United Kingdom, Czechia. 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 10 Feb 2020). 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?
Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis (time frame: Up to 90 days (post initial mapping and ablation procedure)). The study lists 3 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 NCT03437733, which also lists 1 linked publication.
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 29 Jun 2025.