Symptomatic BradycardiaNCT06011252
Pacing Characteristics of a Conventional Bipolar
A study testing Solia S lead with any BIOTRONIK Pacemaker in people with Symptomatic Bradycardia, run by Chang Gung Memorial Hospital at 5 sites in Taiwan.
Trial summary
Study Title: Pacing characteristics of a conventional bipolar, active fixation pacing lead for left bundle branch area pacing in patients with symptomatic bradycardia Study Objectives: To characterize an approach for left bundle branch area pacing (LBBAP) in patients with bradycardia indications for pacing and to… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Symptomatic Bradycardia
- What is being tested?
- Solia S lead with any BIOTRONIK Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 5 sitesTaiwan
- Study dates
- 1 Jan 2023to 16 Jun 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 20 years of age
- Standard bradycardia pacing indications requiring new ventricular lead implantation
- Able to give informed consent for the participation in the trial
Who cannot join
- Patients underwent cardiac resynchronization therapy or implantable cardioverter-defibrillator implantation
- New York Heart Association (NYHA) functional class IV heart failure
- Life expectancy < 1 year
- Right-sided approach for lead implantation
- Hemodialysis or peritoneal dialysis patients
- Pregnant or breast-feeding women
Show all 10Show fewer
- Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
- Participation in another prospective interventional clinical study within a period of 4 weeks prior to the implantation of LBBAP
- Use of any recreational drugs or history of drug addiction
- Any other condition that, in the investigator's judgment, might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Chang Gung Memorial Hospital
Kaohsiung City
Chang Gung Memorial Hospital
Linkou District, Taipei, 10507
China Medical University Hospital
Taichung
MacKay Memorial Hospital
Taipei
National Yang Ming Chiao Tung University Hospital
Yilan
About this study
Official title: Pacing Characteristics of a Conventional Bipolar, Active Fixation Pacing Lead for Left Bundle Branch Area Pacing in Patients With Symptomatic Bradycardia
Study Title:
Pacing characteristics of a conventional bipolar, active fixation pacing lead for left bundle branch area pacing in patients with symptomatic bradycardia
Read more
Study Objectives:
To characterize an approach for left bundle branch area pacing (LBBAP) in patients with bradycardia indications for pacing and to assess implant success rate, safety, and long-term stability with a conventional bipolar, active fixation pacing lead.
Methodology: Open-label, prospective, multi-center, non-randomized, single-arm study
Study Endpoints:
Primary Endpoint:
- Implant success rate
Secondary Endpoints:
- Intra-operative procedure time and fluoroscopic exposure time
- Intra-operative intracardiac electrogram (EGM) changes: paced QRS duration, stimulus to left ventricular (LV) activation time, and LBB potential
- Post-operative imaging data: posteroanterior, left anterior oblique 30O, right anterior oblique 30O, Left lateral views
- Serial paced 12-lead electrocardiogram (ECG) and intracardiac EGM changes: QRS duration (QRSd), pacing-QRS interval, and new atrial fibrillation (AF)
- Serial echocardiography changes: left ventricular ejection fraction (LVEF), left atrial (LA) and LV chamber size, and global longitudinal strain (GLS) of tissue Doppler imaging
- Serial changes of pacing parameters: capture threshold, impedance, and sensing amplitude for both atrial and ventricular Solia S leads
- Safety:
Immediate (< 24 hours), in-hospital, and chronic (12 months) adverse events
Read the detailed description
Patient Enrollment: To target 120 consecutive patients while considering a 20% dropout rate, an approximate sample size of 150 patients is needed.
Treatment Plan:This is a prospective, single-arm, open-label, non-randomized, multi-center study to investigate the feasibility and stability of left bundle branch area pacing (LBBAP) for ventricular pacing in symptomatic bradycardia patients with a conventional bipolar, active fixation pacing lead. Eligible patients will be enrolled through the process of informed consent in the seven clinical investigational sites across Taiwan with competitive enrollment.
All subjects enrolled in the study will undergo LBBAP implantation using one or two Solia S leads in combination with any legally marketed BIOTRONIK pacemaker system delivered through a preshaped sheath (Selectra 3D) via left cephalic, left subclavian, or left axillary venous access. The available lengths of Solia S are 45, 53, and 60 cm. As for which one will be used, it will depend on the lead configuration and the anatomy of the subject. During the screening period, the subject's medical history and demographic information will be collected. The baseline data will be obtained prior to the pacing implantation. Depending on the needs of the subject, the screening and implantation procedures may be performed on the same day. Implant data will include lead measurements, implant technique, and lead positioning. After completion of pacemaker implantation, subjects will be followed at 1, 3, 6, and 12 months or until lead failure (dislodgment, high capture threshold, or inadequate sensing requiring revision of the lead) or death. During follow-up, a determination will be made whether the system is able to provide appropriate pacing and sensing.
Device Description:
Solia Leads: The Solia S is a family of 5.6 French, steroid-eluting, transvenous, endocardial, bipolar active fixation leads with an extendable/retractable and electrically active screw. The Solia S is manufactured, like its predecessor, the Siello S lead, in three different models (45, 53, and 60 cm in length). It has an isodiametric structure and silicone insulation. The inner and outer conductors consist of quadruple wire coils.
Solia S has a diameter of 5.6 F and is covered by a polyurethane overlay for improved gliding. It has an IS-1 connector and a 10 mm pole distance. The area between tip and ring is flexible in order to minimize the perforation risk. The fixation screw of the Solia S is electrically active and has a fractal iridium coating. The screw can be extended by 1.8 mm and has an active surface area of 4.5 mm2. The ring electrode of Solia S has a surface area of approximately 17.4 mm2 and is fractally coated with iridium. The Solia S has a dexamethasone eluting steroid collar containing 0.85 mg dexamethasone acetate. The accessories that are delivered with the lead are identical to the accessories of the Siello S.
Test Device information is below,
- Name: Solia S lead with any BIOTRONIK Pacemaker
- Model: Solia S45/S53/S60
- Manufacturer: BIOTRONIK SE \& Co. KG
- Method of use: LBBAP implantation for all bradycardia indications.
- Mechanism of action: (1) Pacemaker stimulates the cardiac tissue to keep stable heart beats in patients with bradycardia. (2) LBBAP can be an alternative to right ventricular (RV) pacing to reduce RV pacing-induced ventricular dyssynchrony.
- Device category and grade: E3610 Cardiovascular devices, Class III
- Conditions
- Symptomatic Bradycardia
- Being tested
- Solia S lead with any BIOTRONIK Pacemaker
- Keywords
- FF068, Conventional bipolar, symptomatic bradycardia, left bundle branch area pacing, LBBAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solia S lead with any BIOTRONIK PacemakerDevice
- Name: Solia S lead with any BIOTRONIK Pacemaker
- Model: Solia S45/S53/S60
- Manufacturer: BIOTRONIK SE \& Co. KG
- Method of use: LBBAP implantation for all bradycardia indications.
- Mechanism of action: (1) Pacemaker stimulates the cardiac tissue to keep stable heart beats in patients with bradycardia. (2) LBBAP can be an alternative to right ventricular (RV) pacing to reduce RV pacing-induced ventricular dyssynchrony.
- Device category and grade: E3610 Cardiovascular devices, Class III
| Study group | Role | What they receive |
|---|---|---|
| Solia S lead with any BIOTRONIK Pacemaker | Other | * Name: Solia S lead with any BIOTRONIK Pacemaker
* Model: Solia S45/S53/S60
* Manufacturer: BIOTRONIK SE \& Co. KG
* Method of use: LBBAP implantation for all bradycardia indications.
* Mechanism of action: (1) Pacemaker stimulates the cardiac tissue to keep stable heart beats in patients with bradycardia. (2) LBBAP can be an alternative to right ventricular (RV) pacing to reduce RV pacing-induced ventricular dyssynchrony.
* Device category and grade: E3610 Cardiovascular devices, Class III Receives: Device: Solia S lead with any BIOTRONIK Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Success Rate
The purpose of the primary endpoint is to evaluate the overall success rate of the implanted system, including Solia ventricular lead to sense and deliver pacing at 12- month post-implant. Successful sensing performance at 12 months is the demonstrated ability to appropriately sense without intervention for undersensing (i.e., Solia leadrelated adverse event for lead undersensing or loss of sensing) in the period from implant to 12 months, except for normal pulse generator reprogramming. Successful pacing is the demonstrated ability at 12 months to deliver a stimulation pulse with capture, without intervention (i.e., Solia lead-related adverse event for intermittent capture or no lead capture) other than normal pulse generator reprogramming. Success is determined at the subject level.
Measured: Baseline, 12 months
Secondary outcomes (6)
Intra-operative fluoroscopic exposure time
Fluoroscopic exposure time will be measured and recorded during the LBBAP implantation period.
Measured: Baseline, 1 months, 3 months, 6 months ,and 12 months
Intra-operative intracardiac electrogram (EGM)
Intra-operative intracardiac electrogram will be measured and recorded at baseline \& during LBBAP implantation. Paced QRS duration, stimulus to left ventricular (LV) activation time, and LBB potential will be recorded if feasible.
The data are included: Heart Rate (bpm) \& QRSd (ms) \& PR interval (ms) \& QTc interval (ms)
Measured: Baseline, 1 months, 3 months, 6 months ,and 12 months
Post-operative imaging data
X-Ray imaging data is included posteroanterior view, left anterior oblique (30 degree) view, right anterior oblique (30 degree) view, Left lateral views will be collected after LBBAP implantation.
Measured: baseline
Serial paced 12-lead electrocardiogram (ECG) and intracardiac EGM changes
During implantation and follow-up periods, a 12-lead ECG will be recorded along with an intracardiac EGM. The QRS duration (QRSd), pacing-QRS interval, and imaging data, new atrial fibrillation on the surface ECG will be collected and analyzed.
ECG will be recorded with paced AV interval 100ms or sensed AV interval 60ms in patients with intact AV conduction if possible.
Measured: Screen, Baseline, 1 months, 3 months, 6 months ,and 12 months
Serial echocardiography changes
Echocardiography will be performed at baseline and 12-months postimplant to evaluate the changes of the left ventricular ejection fraction (LVEF), left atrial (LA), and left ventricular (LV) chamber size, tissue Doppler global longitudinal strain (GLS) from baseline. Thedata are including LVEF (%) \& LVEDD (mm) \& LAD (mm) \& LVESD (mm) \& IVS (mm) \& LVPW (mm)
Measured: baseline, 12 months
Serial changes of pacing parameters
Pacing parameters, including capture threshold, impedance, and sensing amplitude for both atrial and ventricular Solia S leads will be collected and evaluated at baseline, 1-month, 3-month, 6-month, and 12-months post-implant. Capture threshold measurement will be performed at 0.4 ms pulse width when feasible. The data are including Basic Rate: (min) \& Rest Rate: (min) \& Max Rate: (min) Paced AV delay (ms) \& Sensed AV delay (ms) \& Atrial lead: sensitivity (mV); output _ V@_____ ms \& Ventricular lead: sensitivity (mV) ; output ______ V@_____ ms
Measured: Baseline, 1 months, 3 months, 6 months ,and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jan 2023
- Primary completion31 Mar 2025
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic BradycardiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Model description
- Open-label, prospective, multi-center, non-randomized, single-arm study
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
- Investigators
- Chun Chieh Wang, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011252
- Sponsor's protocol ID
- 202200877A3
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing Characteristics of a Conventional Bipolar, Active Fixation Pacing Lead for Left Bundle Branch Area Pacing in Patients With Symptomatic Bradycardia
- ClinicalTrials.gov ID
- NCT06011252
- Acronym / sponsor ID
- 202200877A3
- Conditions
- Symptomatic Bradycardia
- Keywords
- FF068, Conventional bipolar, symptomatic bradycardia, left bundle branch area pacing, LBBAP
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 25 Aug 2023 (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.
Study Title:
Pacing characteristics of a conventional bipolar, active fixation pacing lead for left bundle branch area pacing in patients with symptomatic bradycardia
Study Objectives:
To characterize an approach for left bundle branch area pacing (LBBAP) in patients with bradycardia indications for pacing and to assess implant success rate, safety, and long-term stability with a conventional bipolar, active fixation pacing lead.
Methodology: Open-label, prospective, multi-center, non-randomized, single-arm study
Study Endpoints:
Primary Endpoint:
- Implant success rate
Secondary Endpoints:
- Intra-operative procedure time and fluoroscopic exposure time
- Intra-operative intracardiac electrogram (EGM) changes: paced QRS duration, stimulus to left ventricular (LV) activation time, and LBB potential
- Post-operative imaging data: posteroanterior, left anterior oblique 30O, right anterior oblique 30O, Left lateral views
- Serial paced 12-lead electrocardiogram (ECG) and intracardiac EGM changes: QRS duration (QRSd), pacing-QRS interval, and new atrial fibrillation (AF)
- Serial echocardiography changes: left ventricular ejection fraction (LVEF), left atrial (LA) and LV chamber size, and global longitudinal strain (GLS) of tissue Doppler imaging
- Serial changes of pacing parameters: capture threshold, impedance, and sensing amplitude for both atrial and ventricular Solia S leads
- Safety:
Immediate (< 24 hours), in-hospital, and chronic (12 months) adverse events
Detailed description
Patient Enrollment: To target 120 consecutive patients while considering a 20% dropout rate, an approximate sample size of 150 patients is needed.
Treatment Plan:This is a prospective, single-arm, open-label, non-randomized, multi-center study to investigate the feasibility and stability of left bundle branch area pacing (LBBAP) for ventricular pacing in symptomatic bradycardia patients with a conventional bipolar, active fixation pacing lead. Eligible patients will be enrolled through the process of informed consent in the seven clinical investigational sites across Taiwan with competitive enrollment.
All subjects enrolled in the study will undergo LBBAP implantation using one or two Solia S leads in combination with any legally marketed BIOTRONIK pacemaker system delivered through a preshaped sheath (Selectra 3D) via left cephalic, left subclavian, or left axillary venous access. The available lengths of Solia S are 45, 53, and 60 cm. As for which one will be used, it will depend on the lead configuration and the anatomy of the subject. During the screening period, the subject's medical history and demographic information will be collected. The baseline data will be obtained prior to the pacing implantation. Depending on the needs of the subject, the screening and implantation procedures may be performed on the same day. Implant data will include lead measurements, implant technique, and lead positioning. After completion of pacemaker implantation, subjects will be followed at 1, 3, 6, and 12 months or until lead failure (dislodgment, high capture threshold, or inadequate sensing requiring revision of the lead) or death. During follow-up, a determination will be made whether the system is able to provide appropriate pacing and sensing.
Device Description:
Solia Leads: The Solia S is a family of 5.6 French, steroid-eluting, transvenous, endocardial, bipolar active fixation leads with an extendable/retractable and electrically active screw. The Solia S is manufactured, like its predecessor, the Siello S lead, in three different models (45, 53, and 60 cm in length). It has an isodiametric structure and silicone insulation. The inner and outer conductors consist of quadruple wire coils.
Solia S has a diameter of 5.6 F and is covered by a polyurethane overlay for improved gliding. It has an IS-1 connector and a 10 mm pole distance. The area between tip and ring is flexible in order to minimize the perforation risk. The fixation screw of the Solia S is electrically active and has a fractal iridium coating. The screw can be extended by 1.8 mm and has an active surface area of 4.5 mm2. The ring electrode of Solia S has a surface area of approximately 17.4 mm2 and is fractally coated with iridium. The Solia S has a dexamethasone eluting steroid collar containing 0.85 mg dexamethasone acetate. The accessories that are delivered with the lead are identical to the accessories of the Siello S.
Test Device information is below,
- Name: Solia S lead with any BIOTRONIK Pacemaker
- Model: Solia S45/S53/S60
- Manufacturer: BIOTRONIK SE \& Co. KG
- Method of use: LBBAP implantation for all bradycardia indications.
- Mechanism of action: (1) Pacemaker stimulates the cardiac tissue to keep stable heart beats in patients with bradycardia. (2) LBBAP can be an alternative to right ventricular (RV) pacing to reduce RV pacing-induced ventricular dyssynchrony.
- Device category and grade: E3610 Cardiovascular devices, Class III
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, prospective, multi-center, non-randomized, single-arm study
| Arm | Type | Receives |
|---|---|---|
| Solia S lead with any BIOTRONIK Pacemaker | Other | Device: Solia S lead with any BIOTRONIK Pacemaker* Name: Solia S lead with any BIOTRONIK Pacemaker * Model: Solia S45/S53/S60 * Manufacturer: BIOTRONIK SE \& Co. KG * Method of use: LBBAP implantation for all bradycardia indications. * Mechanism of action: (1) Pacemaker stimulates the cardiac tissue to keep stable heart beats in patients with bradycardia. (2) LBBAP can be an alternative to right ventricular (RV) pacing to reduce RV pacing-induced ventricular dyssynchrony. * Device category and grade: E3610 Cardiovascular devices, Class III |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients ≥ 20 years of age
- Standard bradycardia pacing indications requiring new ventricular lead implantation
- Able to give informed consent for the participation in the trial
Key exclusion criteria (10 listed)
- Patients underwent cardiac resynchronization therapy or implantable cardioverter-defibrillator implantation
- New York Heart Association (NYHA) functional class IV heart failure
- Life expectancy < 1 year
- Right-sided approach for lead implantation
- Hemodialysis or peritoneal dialysis patients
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 |
|---|---|---|
| Solia S lead with any BIOTRONIK Pacemaker* Name: Solia S lead with any BIOTRONIK Pacemaker * Model: Solia S45/S53/S60 * Manufacturer: BIOTRONIK SE \& Co. KG * Method of use: LBBAP implantation for all bradycardia indications. * Mechanism of action: (1) Pacemaker stimulates the cardiac tissue to keep stable heart beats in patients with bradycardia. (2) LBBAP can be an alternative to right ventricular (RV) pacing to reduce RV pacing-induced ventricular dyssynchrony. * Device category and grade: E3610 Cardiovascular devices, Class III | Device | Solia S lead with any BIOTRONIK Pacemaker |
Primary outcome
Implant Success Rate
Time frame: Baseline, 12 months
The purpose of the primary endpoint is to evaluate the overall success rate of the implanted system, including Solia ventricular lead to sense and deliver pacing at 12- month post-implant. Successful sensing performance at 12 months is the demonstrated ability to appropriately sense without intervention for undersensing (i.e., Solia leadrelated adverse event for lead undersensing or loss of sensing) in the period from implant to 12 months, except for normal pulse generator reprogramming. Successful pacing is the demonstrated ability at 12 months to deliver a stimulation pulse with capture, without intervention (i.e., Solia lead-related adverse event for intermittent capture or no lead capture) other than normal pulse generator reprogramming. Success is determined at the subject level.
6 secondary outcomes
Intra-operative fluoroscopic exposure time
Time frame: Baseline, 1 months, 3 months, 6 months ,and 12 months
Intra-operative intracardiac electrogram (EGM)
Time frame: Baseline, 1 months, 3 months, 6 months ,and 12 months
Post-operative imaging data
Time frame: baseline
Serial paced 12-lead electrocardiogram (ECG) and intracardiac EGM changes
Time frame: Screen, Baseline, 1 months, 3 months, 6 months ,and 12 months
Serial echocardiography changes
Time frame: baseline, 12 months
Serial changes of pacing parameters
Time frame: Baseline, 1 months, 3 months, 6 months ,and 12 months
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 13 May 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. This study is not recruiting at the moment.
Chun Chieh Wang principal investigator
Chang Gung Memorial Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solia S lead with any BIOTRONIK Pacemaker in people with Symptomatic Bradycardia, run by Chang Gung Memorial Hospital at 5 sites in Taiwan.
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 3 inclusion and 10 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 13 May 2026. 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 Taiwan. 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?
Implant Success Rate (time frame: Baseline, 12 months). 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 13 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.