Heart Failure and Reduced Ejection FractionBRIDGE-HFNCT07547306
Evaluation of Accelerated Bachmann Bundle Area Pacing in Heart Failure With Reduced ejectIon Fraction Who Have electrocarDioGraphic Evidence of Interatrial Block and Indicated for Implantable Cardioverter Defibrillator
A study testing BBAP on, BBAP off and RAAP in people with Heart Failure and Reduced Ejection Fraction, run by Seoul National University Hospital.
Trial summary
To evaluate the effect of accelerated atrial resynchronization achieved through Bachmann bundle pacing at the time of implantable cardioverter-defibrillator implantation in patients with heart failure with reduced ejection fraction and interatrial block Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure and Reduced Ejection Fraction
- What is being tested?
- BBAP on, BBAP off and RAAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2026to 31 Dec 2030
- 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
- Age ≥18 years at the time of screening.
- A documented diagnosis of chronic heart failure with New York Heart Association (NYHA) class II-IV.
- Left ventricular ejection fraction (LVEF) ≤40%, documented by an imaging study performed within 12 months prior to screening.
- Receiving optimized guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF), unless contraindicated or not tolerated:
- Participants receiving ongoing treatment must be on a stable regimen for at least 1 month prior to screening (except for diuretics).
- Most patients with heart failure require diuretics for volume control, and dose adjustments may be made based on clinical status, including symptoms, signs, and body weight. Each participant should receive individualized diuretic therapy to maintain optimal volume status.
Show all 10Show fewer
- Presence of interatrial block (IAB), defined as a P-wave duration ≥120 ms on a 12-lead electrocardiogram or ECG recording device.
- An indication for dual-chamber implantable cardioverter-defibrillator (ICD) implantation for primary or secondary prevention.
- NT-proBNP measured within 3 months prior to randomization meeting one of the following criteria:
- NT-proBNP >300 pg/mL
Who cannot join
- Non-paroxysmal AF.
- Uncontrolled tachyarrhythmia.
- Sinus bradycardia requiring continuous atrial pacing or atrioventricular block requiring ventricular pacing.
- Acute decompensated heart failure at the time of screening or hospitalization for worsening heart failure within 4 weeks prior to enrollment.
- Moderate to severe primary valvular heart disease (functional mitral regurgitation or tricuspid regurgitation is not an exclusion criterion).
- Prior mechanical tricuspid valve replacement.
Show all 17Show fewer
- Coronary revascularization (PCI or CABG) or valve surgery/repair performed within 12 weeks prior to enrollment, or planned after randomization.
- Obstructive hypertrophic cardiomyopathy.
- Infiltrative cardiomyopathy, including but not limited to amyloidosis, sarcoidosis, or Fabry disease.
- An indication for cardiac resynchronization therapy (CRT).
- Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m² calculated using the CKD-EPI equation.
- Chronic liver disease, defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase >3 times the upper limit of normal at screening.
- Severe pulmonary disease, such as cor pulmonale or irreversible lung disease requiring inhaled therapy or long-term oxygen therapy.
- Uncontrolled hypertension, defined as a mean blood pressure >140/90 mmHg based on outpatient clinic measurements or home blood pressure recordings within the previous 30 days, or ongoing up-titration of antihypertensive medications.
- Pregnant or breastfeeding women, or women planning pregnancy or breastfeeding during the study period.
- Active malignancy requiring treatment at the time of screening.
- Life expectancy <12 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the effect of accelerated atrial resynchronization achieved through Bachmann bundle pacing at the time of implantable cardioverter-defibrillator implantation in patients with heart failure with reduced ejection fraction and interatrial block
Read the detailed description
Interatrial block (IAB) is a distinct electrocardiographic finding resulting from delayed conduction between the right and left atria through Bachmann's bundle (BB). In a prevalence study of non-hospitalized individuals aged 65 years or older in sinus rhythm, IAB was observed in 59% of participants. With population aging and improved survival among patients with cardiovascular comorbidities, the prevalence of IAB is expected to increase further. Importantly, IAB leads to delayed left atrial contraction and impaired left ventricular diastolic filling, pathophysiological features commonly observed in heart failure (HF) that contribute to worsening HF symptoms.
Bachmann bundle area pacing (BBAP) has emerged as an attractive alternative to conventional right atrial appendage (RAA) pacing. Recent studies have demonstrated that BBAP, when guided by intracardiac electrograms and implemented using sheath-assisted atrial lead implantation techniques, is a safe and feasible approach for effectively correcting IAB. Echocardiographic data have shown that BBAP induces biatrial resynchronization. In clinical studies involving patients with heart failure with preserved ejection fraction (HFpEF), BBAP has been associated with significant clinical benefits, including improvements in quality of life, increased physical activity, and reductions in NT-proBNP levels. In these HFpEF studies, the clinical effects of BBAP were evaluated using physiologically accelerated pacing (approximately 70 beats per minute or individualized fine-tuned accelerated pacing based on body size and left ventricular ejection fraction), with particularly notable benefits observed in the improvement of diastolic function.
Despite these promising findings, the role of BBAP and BBAP-mediated accelerated pacing in patients with heart failure with reduced ejection fraction (HFrEF) has not yet been clearly established. In animal (porcine) models, improvement in atrial synchrony achieved through BBAP has been shown to significantly increase left ventricular stroke volume compared with conventional RAA pacing, as confirmed by comprehensive hemodynamic analyses. However, despite the potential advantages of this more physiological pacing strategy, human data evaluating BBAP in patients with HFrEF remain limited.
Accordingly, the present study aims to evaluate the clinical effects of atrial resynchronization achieved through accelerated BBAP in patients with HFrEF accompanied by interatrial block who meet indications for implantable cardioverter-defibrillator implantation.
- Being tested
- BBAP on, BBAP off, RAAP
- Keywords
- heart failure and reduced ejection fraction, Bachmann bundle area pacing, interatrial block
- Medical subject headings
- Heart Failure, Systolic, Interatrial Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBAP onDevice
ICD programmed for 6 weeks with LRL 70 beats/min, DDDR, and APP enabled.
BBAP offDevice
ICD programmed for 6 weeks with an LRL 30 beats/min in VVI mode
RAAPDrug
ICD programmed for 6 weeks with LRL 70 beats/min, DDDR, and APP enabled.
| Study group | Role | What they receive |
|---|---|---|
| BBAP on | Experimental | In the Bachmann bundle pacing ON group, the implantable cardioverter-defibrillator will be programmed for 6 weeks with a lower rate limit (LRL) of 70 beats per minute, DDDR mode, and atrial preference pacing (APP) enabled.
After the initial 6-week randomized period, to eliminate the effects of prior pacing, the implantable cardioverter-defibrillator in both groups will be reprogrammed to an LRL of 30 beats per minute in VVI mode, followed by a 4-week washout period.
After the washout period, participants will undergo crossover, such that those initially assigned to the Bachmann bundle pacing ON group will be switched to the OFF group, and those initially assigned to the OFF group will be switched to the ON group, with the assigned pacing mode maintained for an additional 6 weeks. Receives: Device: BBAP on |
| BBAP off | Active comparator | In the Bachmann bundle pacing OFF group, the implantable cardioverter-defibrillator will be programmed for 6 weeks with an LRL of 30 beats per minute in VVI mode.
After the initial 6-week randomized period, to eliminate the effects of prior pacing, the implantable cardioverter-defibrillator in both groups will be reprogrammed to an LRL of 30 beats per minute in VVI mode, followed by a 4-week washout period.
After the washout period, participants will undergo crossover, such that those initially assigned to the Bachmann bundle pacing ON group will be switched to the OFF group, and those initially assigned to the OFF group will be switched to the ON group, with the assigned pacing mode maintained for an additional 6 weeks. Receives: Device: BBAP off |
| RAAP on | Other | A comparator cohort receiving accelerated atrial resynchronization via right atrial appendage pacing will be enrolled separately at institutions distinct from those recruiting participants for Bachmann bundle pacing. In the right atrial appendage pacing cohort, the implantable cardioverter-defibrillator will be programmed for the initial 6 weeks with an LRL of 70 beats per minute, DDDR mode, and atrial preference pacing enabled. Individualized adjustment of the LRL will be permitted at the investigator's discretion based on the patient's clinical status. Receives: Drug: RAAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in NT-proBNP at 6 weeks (accelerated Bachmann bundle area pacing ON) compared with baseline (accelerated Bachmann bundle area pacing OFF).
Measured: up to 6 weeks
Secondary outcomes (13)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 6 weeks, 16 weeks, and 12 months compared with baseline.
Measured: up to 12 months
Changes in E and A wave velocity (m/s) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.
Measured: up to 12 months
Changes in E/A and E/E' ratios on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.
Measured: up to 12 months
Change in left atrial diameter (mm) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.
Measured: up to 12 months
Change in left atrial strain (%) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline
Measured: up to 12 months
Change in left atrial volume index (LAVI, ml/m2) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.
Measured: up to 12 months
Change in left ventricular ejection fraction (LVEF) at 6 weeks, 16 weeks, and 12 months compared with baseline.
Measured: up to 12 months
Change in NYHA functional class at 6 weeks, 16 weeks, and 12 months.
Measured: up to 12 months
Change in peak oxygen consumption (VO₂ max) at 6 weeks, 16 weeks, and 12 months compared with baseline.
Measured: up to 12 months
Incidence of newly detected atrial fibrillation (AF).
Measured: up to 12 months
Atrial fibrillation (AF) burden (%)
Measured: up to 12 months
Change in 6-minute walk distance (6MWD) compared with baseline.
Measured: up to 12 months
The occurence of clinical outcomes at 12 months, including: a) All-cause mortality, b) Worsening heart failure, regardless of hospitalization*, and c) Composite outcome of (a) and (b)
- Worsening heart failure is defined as deterioration in symptoms, signs, imaging, or laboratory findings requiring unplanned medical intervention, including up-titration of oral diuretics or administration of intravenous diuretics.
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 posted23 Apr 2026
- Study startMay 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure and Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Randomised
- Intervention model
- Crossover
- Model description
- The primary hypothesis will be evaluated through randomized allocation. For secondary analyses, a comparative assessment of effectiveness and safety versus the commonly used approach of accelerated atrial resynchronization via right atrial appendage pacing is deemed necessary; therefore, patients treated with right atrial appendage pacing will be prospectively enrolled as a separate cohort at institutions distinct from those recruiting for Bachmann bundle pacing
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Eue-Keun Choi, Seoul National University Hospital
- Investigators
- Eue-Keun Choi, M.D. Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547306
- Sponsor's protocol ID
- BRIDGE-HF
- Acronym
- BRIDGE-HF
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accelerated Bachmann Bundle Area Pacing in Heart Failure With Reduced ejectIon Fraction Who Have electrocarDioGraphic Evidence of Interatrial Block and Indicated for Implantable Cardioverter Defibrillator
- ClinicalTrials.gov ID
- NCT07547306
- Acronym / sponsor ID
- BRIDGE-HF / BRIDGE-HF
- Keywords
- heart failure and reduced ejection fraction, Bachmann bundle area pacing, interatrial block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- May 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of accelerated atrial resynchronization achieved through Bachmann bundle pacing at the time of implantable cardioverter-defibrillator implantation in patients with heart failure with reduced ejection fraction and interatrial block
Detailed description
Interatrial block (IAB) is a distinct electrocardiographic finding resulting from delayed conduction between the right and left atria through Bachmann's bundle (BB). In a prevalence study of non-hospitalized individuals aged 65 years or older in sinus rhythm, IAB was observed in 59% of participants. With population aging and improved survival among patients with cardiovascular comorbidities, the prevalence of IAB is expected to increase further. Importantly, IAB leads to delayed left atrial contraction and impaired left ventricular diastolic filling, pathophysiological features commonly observed in heart failure (HF) that contribute to worsening HF symptoms.
Bachmann bundle area pacing (BBAP) has emerged as an attractive alternative to conventional right atrial appendage (RAA) pacing. Recent studies have demonstrated that BBAP, when guided by intracardiac electrograms and implemented using sheath-assisted atrial lead implantation techniques, is a safe and feasible approach for effectively correcting IAB. Echocardiographic data have shown that BBAP induces biatrial resynchronization. In clinical studies involving patients with heart failure with preserved ejection fraction (HFpEF), BBAP has been associated with significant clinical benefits, including improvements in quality of life, increased physical activity, and reductions in NT-proBNP levels. In these HFpEF studies, the clinical effects of BBAP were evaluated using physiologically accelerated pacing (approximately 70 beats per minute or individualized fine-tuned accelerated pacing based on body size and left ventricular ejection fraction), with particularly notable benefits observed in the improvement of diastolic function.
Despite these promising findings, the role of BBAP and BBAP-mediated accelerated pacing in patients with heart failure with reduced ejection fraction (HFrEF) has not yet been clearly established. In animal (porcine) models, improvement in atrial synchrony achieved through BBAP has been shown to significantly increase left ventricular stroke volume compared with conventional RAA pacing, as confirmed by comprehensive hemodynamic analyses. However, despite the potential advantages of this more physiological pacing strategy, human data evaluating BBAP in patients with HFrEF remain limited.
Accordingly, the present study aims to evaluate the clinical effects of atrial resynchronization achieved through accelerated BBAP in patients with HFrEF accompanied by interatrial block who meet indications for implantable cardioverter-defibrillator implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The primary hypothesis will be evaluated through randomized allocation. For secondary analyses, a comparative assessment of effectiveness and safety versus the commonly used approach of accelerated atrial resynchronization via right atrial appendage pacing is deemed necessary; therefore, patients treated with right atrial appendage pacing will be prospectively enrolled as a separate cohort at institutions distinct from those recruiting for Bachmann bundle pacing
| Arm | Type | Receives |
|---|---|---|
| BBAP on | Experimental | Device: BBAP onIn the Bachmann bundle pacing ON group, the implantable cardioverter-defibrillator will be programmed for 6 weeks with a lower rate limit (LRL) of 70 beats per minute, DDDR mode, and atrial preference pacing (APP) enabled. After the initial 6-week randomized period, to eliminate the effects of prior pacing, the implantable cardioverter-defibrillator in both groups will be reprogrammed to an LRL of 30 beats per minute in VVI mode, followed by a 4-week washout period. After the washout period, participants will undergo crossover, such that those initially assigned to the Bachmann bundle pacing ON group will be switched to the OFF group, and those initially assigned to the OFF group will be switched to the ON group, with the assigned pacing mode maintained for an additional 6 weeks. |
| BBAP off | Active comparator | Device: BBAP offIn the Bachmann bundle pacing OFF group, the implantable cardioverter-defibrillator will be programmed for 6 weeks with an LRL of 30 beats per minute in VVI mode. After the initial 6-week randomized period, to eliminate the effects of prior pacing, the implantable cardioverter-defibrillator in both groups will be reprogrammed to an LRL of 30 beats per minute in VVI mode, followed by a 4-week washout period. After the washout period, participants will undergo crossover, such that those initially assigned to the Bachmann bundle pacing ON group will be switched to the OFF group, and those initially assigned to the OFF group will be switched to the ON group, with the assigned pacing mode maintained for an additional 6 weeks. |
| RAAP on | Other | Drug: RAAPA comparator cohort receiving accelerated atrial resynchronization via right atrial appendage pacing will be enrolled separately at institutions distinct from those recruiting participants for Bachmann bundle pacing. In the right atrial appendage pacing cohort, the implantable cardioverter-defibrillator will be programmed for the initial 6 weeks with an LRL of 70 beats per minute, DDDR mode, and atrial preference pacing enabled. Individualized adjustment of the LRL will be permitted at the investigator's discretion based on the patient's clinical status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years at the time of screening.
- A documented diagnosis of chronic heart failure with New York Heart Association (NYHA) class II-IV.
- Left ventricular ejection fraction (LVEF) ≤40%, documented by an imaging study performed within 12 months prior to screening.
- Receiving optimized guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF), unless contraindicated or not tolerated:
- Presence of interatrial block (IAB), defined as a P-wave duration ≥120 ms on a 12-lead electrocardiogram or ECG recording device.
Key exclusion criteria (17 listed)
- Non-paroxysmal AF.
- Uncontrolled tachyarrhythmia.
- Sinus bradycardia requiring continuous atrial pacing or atrioventricular block requiring ventricular pacing.
- Acute decompensated heart failure at the time of screening or hospitalization for worsening heart failure within 4 weeks prior to enrollment.
- Moderate to severe primary valvular heart disease (functional mitral regurgitation or tricuspid regurgitation is not an exclusion criterion).
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 |
|---|---|---|
| BBAP onICD programmed for 6 weeks with LRL 70 beats/min, DDDR, and APP enabled. | Device | BBAP on |
| BBAP offICD programmed for 6 weeks with an LRL 30 beats/min in VVI mode | Device | BBAP off |
| RAAPICD programmed for 6 weeks with LRL 70 beats/min, DDDR, and APP enabled. | Drug | RAAP on |
Primary outcome
Relative change in NT-proBNP at 6 weeks (accelerated Bachmann bundle area pacing ON) compared with baseline (accelerated Bachmann bundle area pacing OFF).
Time frame: up to 6 weeks
13 secondary outcomes
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 6 weeks, 16 weeks, and 12 months compared with baseline.
Time frame: up to 12 months
Changes in E and A wave velocity (m/s) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.
Time frame: up to 12 months
Changes in E/A and E/E' ratios on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.
Time frame: up to 12 months
Change in left atrial diameter (mm) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.
Time frame: up to 12 months
Change in left atrial strain (%) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline
Time frame: up to 12 months
Change in left atrial volume index (LAVI, ml/m2) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.
Time frame: up to 12 months
Change in left ventricular ejection fraction (LVEF) at 6 weeks, 16 weeks, and 12 months compared with baseline.
Time frame: up to 12 months
Change in NYHA functional class at 6 weeks, 16 weeks, and 12 months.
Time frame: up to 12 months
Change in peak oxygen consumption (VO₂ max) at 6 weeks, 16 weeks, and 12 months compared with baseline.
Time frame: up to 12 months
Incidence of newly detected atrial fibrillation (AF).
Time frame: up to 12 months
Atrial fibrillation (AF) burden (%)
Time frame: up to 12 months
Change in 6-minute walk distance (6MWD) compared with baseline.
Time frame: up to 12 months
The occurence of clinical outcomes at 12 months, including: a) All-cause mortality, b) Worsening heart failure, regardless of hospitalization*, and c) Composite outcome of (a) and (b)
Time frame: up to 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 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Eue-Keun Choi, M.D. Ph.D. principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing BBAP on, BBAP off and RAAP in people with Heart Failure and Reduced Ejection Fraction, run by Seoul National University Hospital.
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 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eue-Keun Choi, M.D. Ph.D. (82-2-2072-0688, choiek417@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in NT-proBNP at 6 weeks (accelerated Bachmann bundle area pacing ON) compared with baseline (accelerated Bachmann bundle area pacing OFF). (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.