Aortic Valve StenosisNCT05171712

Portico and Navitor India Clinical Trial

A study testing Transcatheter Aortic Valve Replacement in people with Aortic Valve Stenosis and Aortic Valve Failure, run by Abbott Medical Devices at 6 sites in India.

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 this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian population. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency
What is being tested?: Transcatheter Aortic Valve Replacement
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 6 sitesIndia
Study dates: 6 May 2022to 28 Jan 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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject must provide written informed consent prior to any clinical investigation-related procedure.
Are >60 years of age in host country, have severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), at high or extreme surgical risk and have been identified as a candidate for a Portico or Navitor valve implant.
Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.

Who cannot join

Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any time AND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.)
Have sepsis, including active endocarditis
Have any evidence of left ventricular or atrial thrombus
Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
Have a non-calcified aortic annulus
Have congenital bicuspid or unicuspid leaflet configuration

Show all 9Show fewer

Are unable to tolerate antiplatelet/anticoagulant therapy
Are pregnant at the time of signing informed consent
Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

India6 sites

Apollo Hospital
Chennai
Medanta-The Medicity
Gūrgaon
Rajasthan Hospital
Jaipur
Seth GS Medical College & KEM Hospital
Mumbai
Vardhman Mahavir Medical College & Safdarjung Hospital
New Delhi
Christian Medical College & Hospital
Vellore

Other trials in India

About this study

Read the detailed description

The objective of this Phase IV clinical trial is to characterize the procedural safety and device performance of the Portico valve, the Navitor Valve, the FlexNav delivery system and FlexNav or Navitor loading system to treat patients with severe aortic stenosis.

Conditions: Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
Being tested: Transcatheter Aortic Valve Replacement
Medical subject headings: Aortic Valve Stenosis, Aortic Valve Insufficiency

What participants receive

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

Transcatheter Aortic Valve ReplacementDevice
Transcatheter Aortic Valve Replacement for the treatment of patients with severe aortic stenosis

Study groups in NCT05171712
Study group	Role	What they receive
Analysis Population	Experimental	The analysis population will include patients considered at high or extreme surgical risk, who have met all inclusion criteria, have not met any exclusion criteria, have signed an Ethics Committee (EC) approved Informed Consent, and, at the minimum, the FlexNav delivery system entered his/her vasculature for an attempted Portico or Navitor Valve implant Receives: Device: Transcatheter Aortic Valve Replacement

What is being measured

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

VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 30 days post index procedure
VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 30 days post index procedure
Myocardial Infarction Rate
Myocardial Infarction rate: percent of subjects who experienced a myocardial infarction within 30 days of the implant/index procedure
Measured: 30 days post index procedure
VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 30 days post index procedure
VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 30 days post index procedure
VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 30 days post index procedure
VARC-2 Defined Event Rate of Vascular Access Site and Access-related Complications (Major and Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 30 days post index procedure
VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 30 days post index procedure
VARC-2 Defined Event Rate of Permanent Pacemaker Insertion (Percent of Subjects) at 30 Days From the Implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 30 days post index procedure
Percentage of Subjects With Implant Success
Defined as absence of procedural mortality, correct positioning of a single Portico prosthetic heart valve into the proper anatomical location, no conversion to open surgery
Measured: During procedure
Echocardiographic Assessment of the Mean Aortic Gradient
Units=mmHg
Measured: 30 days post index procedure
Echocardiographic Assessment of Effective Orifice Area (EOA)
units = cm2
Measured: 30 days post index procedure
Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days.
Reported as either none/trace, mild, moderate, or severe
Measured: 30 days post index procedure
VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 9 months post index procedure
VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/Index Procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:
1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Measured: 9 months post index procedure
New York Heart Association (NYHA) Functional Class
Reported as the percent of subjects by NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV.
Measured: 30 days post index procedure
New York Heart Association (NYHA) Functional Class
Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have NYHA Class assessed are not presented.
Measured: 9 months post index procedure
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire
Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group.
Measured: 30 Days
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire
Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group.
Measured: 9 Months

Timeline

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

6 May 202228 Jan 2025

First posted29 Dec 2021
Study start6 May 2022
Primary completion21 Dec 2024
Study completion28 Jan 2025

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.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe 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
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05171712
Sponsor's protocol ID: ABT-CIP-10387
Status last verified: Apr 2026
First submitted: 28 Oct 2021
Last updated: 15 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Portico and Navitor India Clinical Trial
ClinicalTrials.gov ID: NCT05171712
Acronym / sponsor ID: ABT-CIP-10387
Conditions: Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 6 May 2022 (actual)
Primary completion: 21 Dec 2024 (actual)
Study completion: 28 Jan 2025 (actual)
First posted: 29 Dec 2021 (actual)
Results: Posted 15 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Analysis Population	Experimental	Device: Transcatheter Aortic Valve ReplacementThe analysis population will include patients considered at high or extreme surgical risk, who have met all inclusion criteria, have not met any exclusion criteria, have signed an Ethics Committee (EC) approved Informed Consent, and, at the minimum, the FlexNav delivery system entered his/her vasculature for an attempted Portico or Navitor Valve implant

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject must provide written informed consent prior to any clinical investigation-related procedure.
Are >60 years of age in host country, have severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), at high or extreme surgical risk and have been identified as a candidate for a Portico or Navitor valve implant.
Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.

Key exclusion criteria (9 listed)

Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any time AND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.)
Have sepsis, including active endocarditis
Have any evidence of left ventricular or atrial thrombus
Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
Have a non-calcified aortic annulus

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
Transcatheter Aortic Valve ReplacementTranscatheter Aortic Valve Replacement for the treatment of patients with severe aortic stenosis	Device	Analysis Population

Primary outcome

VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time frame: 30 days post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time frame: 30 days post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Myocardial Infarction Rate
Time frame: 30 days post index procedure
Myocardial Infarction rate: percent of subjects who experienced a myocardial infarction within 30 days of the implant/index procedure
VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time frame: 30 days post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time frame: 30 days post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time frame: 30 days post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
VARC-2 Defined Event Rate of Vascular Access Site and Access-related Complications (Major and Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time frame: 30 days post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time frame: 30 days post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
VARC-2 Defined Event Rate of Permanent Pacemaker Insertion (Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time frame: 30 days post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Percentage of Subjects With Implant Success
Time frame: During procedure
Defined as absence of procedural mortality, correct positioning of a single Portico prosthetic heart valve into the proper anatomical location, no conversion to open surgery
Echocardiographic Assessment of the Mean Aortic Gradient
Time frame: 30 days post index procedure
Units=mmHg
Echocardiographic Assessment of Effective Orifice Area (EOA)
Time frame: 30 days post index procedure
units = cm2
Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days.
Time frame: 30 days post index procedure
Reported as either none/trace, mild, moderate, or severe
VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/Index Procedure
Time frame: 9 months post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/Index Procedure
Time frame: 9 months post index procedure
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
New York Heart Association (NYHA) Functional Class
Time frame: 30 days post index procedure
Reported as the percent of subjects by NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV.
New York Heart Association (NYHA) Functional Class
Time frame: 9 months post index procedure
Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have NYHA Class assessed are not presented.
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire
Time frame: 30 Days
Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group.
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire
Time frame: 9 Months
Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group.

Results and safety

Results posted to the registry on 15 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Portico Valve	20	17
Navitor Valve	10	10

Primary outcome: VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure

Time frame: 30 days post index procedure. Count of participants. Unit: Participants

Measure	Portico Valve n = 20	Navitor Valve n = 10
Value	3	0

Primary outcome: VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure

Time frame: 30 days post index procedure. Count of participants. Unit: Participants

Measure	Portico Valve n = 20	Navitor Valve n = 10
Value	2	0

Primary outcome: Myocardial Infarction Rate

Time frame: 30 days post index procedure. Count of participants. Unit: Participants

Measure	Portico Valve n = 20	Navitor Valve n = 10
Value	0	0

Primary outcome: VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/Index Procedure

Time frame: 30 days post index procedure. Count of participants. Unit: Participants

Measure	Portico Valve n = 20	Navitor Valve n = 10
Value	0	0

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Portico Valve	7 of 20 (35%)	10 of 20 (50%)	3 of 20
Navitor Valve	1 of 10 (10%)	7 of 10 (70%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Stenosis

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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.

Barathi Sethuraman study director

Abbott

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Aortic Valve Replacement in people with Aortic Valve Stenosis and Aortic Valve Failure, run by Abbott Medical Devices at 6 sites in India.

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 9 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in India. 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 15 Apr 2026). 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?

VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure (time frame: 30 days post index procedure). The study lists 19 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 NCT05171712.

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 15 Apr 2026.