Atrioventricular Block, Second and Third DegreePACE-4-TAVINCT05966675
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
A study testing conduction system pacing and right ventricular or biventricular pacing in people with Atrioventricular Block, Second and Third Degree, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrioventricular Block, Second and Third Degree
- What is being tested?
- conduction system pacing and right ventricular or biventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 27 Feb 2024to Jun 2028
- 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
- transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation
- Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
- Written informed consent
- Age of at least 18 years
Who cannot join
- Permanent pacemaker implantation before TAVI procedure
- The occurrence of conduction disturbances more than 30 days after TAVI procedure
- No written informed consent
- Inability to obtain informed consent from participant
- Predicted inability to obtain cooperation from patient during observation period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tomasz Soral, MD contact
Poland1 site, 1 recruiting
- Recruiting
Medical University of Silesia in Katowice
Katowice
Krzysztof S. Gołba, MD PhD, k.golba@sum.edu.pl
Tomasz Soral, MD, tomasz.soral@gmail.com
About this study
Official title: Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).
Read the detailed description
A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RVP or BVP (control group). The study population will consist of patients hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI within 30 days after surgery, following the 2021 European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy.
- Being tested
- conduction system pacing, right ventricular or biventricular pacing
- Keywords
- Pacemaker, Transcatheter Aortic Valve Replacement, Conduction System Pacing (CSP), Atrioventricular Block, Congestive Heart Failure, Bradycardia
- Medical subject headings
- Atrioventricular Block, Neoplasm Metastasis, Heart Failure, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conduction system pacingDevice
Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).
right ventricular or biventricular pacingDevice
Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Conduction System Pacing | Experimental | Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing. Receives: Device: conduction system pacing |
| Standard Pacing Method | Active comparator | Patients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF >= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines. Receives: Device: right ventricular or biventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Failure Hospitalization
Hospitalization due to heart failure as a main reason
Measured: 12 months
All-cause death
Death from any cause
Measured: 12 months
Secondary outcomes (8)
Change in exercise capacity
Improvement or deterioration in exercise capacity assessed as a change of ≥1 New York Heart Association (NYHA) functional class or a change in 6-Minute Walk Test (6MWT) distance by 55m or more
Measured: 24 months
Response to Cardiac Resynchronization Therapy (CRT)
Meeting the echocardiographic criteria of response to CRT defined as a decrease in Left Ventricular End Systolic Volume by ≥15% or an increase in Left Ventricular Ejection Fraction by ≥5% from the baseline values
Measured: 24 months
Pacing-Induced Cardiomyopathy (PICM)
Pacing-related CHF meeting the echocardiographic criteria of PICM defined as a decrease in LVEF by >=10% to the absolute value of <50%
Measured: 24 months
Change in global longitudinal strain (GLS)
An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%.
Measured: 24 months
Atrial Fibrillation (AF) episodes
Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF).
Measured: 24 months
Atrial High Rate Episodes (AHRE) in pacemaker recordings
Occurrence or change of the burden of AHRE events in the records from the CIED.
Measured: 24 months
Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)
pl/mL
Measured: 24 months
Change in Quality of Life
Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start27 Feb 2024
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular Block, Second and Third DegreeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to the intervention and control groups. In the control group, the type of ventricular pacing will depend on the left ventricular ejection fraction (LVEF): 1) RVP is planned in the group of patients with LVEF ≥40%, 2) BVP is planned in the group of patients with LVEF \<40%, following current ESC guidelines.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
- Investigators
- Krzysztof S. Gołba, MD PhD, Study chair, Silesian Medical University in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966675
- Sponsor's protocol ID
- 2022/ABM/03/00049
- Acronym
- PACE-4-TAVI
- Status last verified
- Jun 2025
- First submitted
- 20 Jul 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
PubMed 34455430Shimony A, Eisenberg MJ, Filion KB, Amit G. Beneficial effects of right ventricular non-apical vs. apical pacing: a systematic review and meta-analysis of randomized-controlled trials. Europace. 2012 Jan;14(1):81-91. doi: 10.1093/europace/eur240. Epub 2011 Jul 27.
PubMed 21798880Daubert JC, Ritter P, Le Breton H, Gras D, Leclercq C, Lazarus A, Mugica J, Mabo P, Cazeau S. Permanent left ventricular pacing with transvenous leads inserted into the coronary veins. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):239-45. doi: 10.1111/j.1540-8159.1998.tb01096.x.
PubMed 9474680Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016 Jun;13(6):1362-6. doi: 10.1016/j.hrthm.2016.03.040. Epub 2016 Mar 22. No abstract available.
PubMed 27016475Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.
PubMed 31233818Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Vijayaraman P, Czarnecka D. Programmed His Bundle Pacing: A Novel Maneuver for the Diagnosis of His Bundle Capture. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e007052. doi: 10.1161/CIRCEP.118.007052.
PubMed 30707037Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Kusiak A, Sondej T, Bednarski A, Vijayaraman P, Czarnecka D. Programmed deep septal stimulation: A novel maneuver for the diagnosis of left bundle branch capture during permanent pacing. J Cardiovasc Electrophysiol. 2020 Feb;31(2):485-493. doi: 10.1111/jce.14352. Epub 2020 Jan 20.
PubMed 31930753Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.
PubMed 25616819Xi Z, Liu T, Liang J, Zhou YJ, Liu W. Impact of postprocedural permanent pacemaker implantation on clinical outcomes after transcatheter aortic valve replacement: a systematic review and meta-analysis. J Thorac Dis. 2019 Dec;11(12):5130-5139. doi: 10.21037/jtd.2019.12.02.
PubMed 32030230Xu S, Zhang E, Qian Z, Sun J, Zou F, Wang Y, Hou X, Zou J. Mid- to Long-Term Clinical and Echocardiographic Effects of Post-procedural Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Front Cardiovasc Med. 2022 Jun 28;9:911234. doi: 10.3389/fcvm.2022.911234. eCollection 2022.
PubMed 35837611Fadahunsi OO, Olowoyeye A, Ukaigwe A, Li Z, Vora AN, Vemulapalli S, Elgin E, Donato A. Incidence, Predictors, and Outcomes of Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2189-2199. doi: 10.1016/j.jcin.2016.07.026.
PubMed 27832844
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05966675
- Acronym / sponsor ID
- PACE-4-TAVI / 2022/ABM/03/00049
- Keywords
- Pacemaker, Transcatheter Aortic Valve Replacement, Conduction System Pacing (CSP), Atrioventricular Block, Congestive Heart Failure, Bradycardia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 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.
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).
Detailed description
A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RVP or BVP (control group). The study population will consist of patients hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI within 30 days after surgery, following the 2021 European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to the intervention and control groups. In the control group, the type of ventricular pacing will depend on the left ventricular ejection fraction (LVEF): 1) RVP is planned in the group of patients with LVEF ≥40%, 2) BVP is planned in the group of patients with LVEF <40%, following current ESC guidelines.
| Arm | Type | Receives |
|---|---|---|
| Conduction System Pacing | Experimental | Device: conduction system pacingPatients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing. |
| Standard Pacing Method | Active comparator | Device: right ventricular or biventricular pacingPatients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF >= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation
- Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
- Written informed consent
- Age of at least 18 years
Key exclusion criteria (5 listed)
- Permanent pacemaker implantation before TAVI procedure
- The occurrence of conduction disturbances more than 30 days after TAVI procedure
- No written informed consent
- Inability to obtain informed consent from participant
- Predicted inability to obtain cooperation from patient during observation period
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 |
|---|---|---|
| conduction system pacingImplantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing). | Device | Conduction System Pacing |
| right ventricular or biventricular pacingImplantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines. | Device | Standard Pacing Method |
Primary outcome
Heart Failure Hospitalization
Time frame: 12 months
Hospitalization due to heart failure as a main reason
All-cause death
Time frame: 12 months
Death from any cause
8 secondary outcomes
Change in exercise capacity
Time frame: 24 months
Response to Cardiac Resynchronization Therapy (CRT)
Time frame: 24 months
Pacing-Induced Cardiomyopathy (PICM)
Time frame: 24 months
Change in global longitudinal strain (GLS)
Time frame: 24 months
Atrial Fibrillation (AF) episodes
Time frame: 24 months
Atrial High Rate Episodes (AHRE) in pacemaker recordings
Time frame: 24 months
Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: 24 months
Change in Quality of Life
Time frame: 24 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 8 Jun 2025.
- Background: PubMed 34455430Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
- Background: PubMed 21798880Shimony A, Eisenberg MJ, Filion KB, Amit G. Beneficial effects of right ventricular non-apical vs. apical pacing: a systematic review and meta-analysis of randomized-controlled trials. Europace. 2012 Jan;14(1):81-91. doi: 10.1093/europace/eur240. Epub 2011 Jul 27.
- Background: PubMed 9474680Daubert JC, Ritter P, Le Breton H, Gras D, Leclercq C, Lazarus A, Mugica J, Mabo P, Cazeau S. Permanent left ventricular pacing with transvenous leads inserted into the coronary veins. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):239-45. doi: 10.1111/j.1540-8159.1998.tb01096.x.
- Background: PubMed 27016475Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016 Jun;13(6):1362-6. doi: 10.1016/j.hrthm.2016.03.040. Epub 2016 Mar 22. No abstract available.
- Background: PubMed 31233818Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.
- Background: PubMed 30707037Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Vijayaraman P, Czarnecka D. Programmed His Bundle Pacing: A Novel Maneuver for the Diagnosis of His Bundle Capture. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e007052. doi: 10.1161/CIRCEP.118.007052.
- Background: PubMed 31930753Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Kusiak A, Sondej T, Bednarski A, Vijayaraman P, Czarnecka D. Programmed deep septal stimulation: A novel maneuver for the diagnosis of left bundle branch capture during permanent pacing. J Cardiovasc Electrophysiol. 2020 Feb;31(2):485-493. doi: 10.1111/jce.14352. Epub 2020 Jan 20.
- Background: PubMed 25616819Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.
- Background: PubMed 32030230Xi Z, Liu T, Liang J, Zhou YJ, Liu W. Impact of postprocedural permanent pacemaker implantation on clinical outcomes after transcatheter aortic valve replacement: a systematic review and meta-analysis. J Thorac Dis. 2019 Dec;11(12):5130-5139. doi: 10.21037/jtd.2019.12.02.
- Background: PubMed 35837611Xu S, Zhang E, Qian Z, Sun J, Zou F, Wang Y, Hou X, Zou J. Mid- to Long-Term Clinical and Echocardiographic Effects of Post-procedural Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Front Cardiovasc Med. 2022 Jun 28;9:911234. doi: 10.3389/fcvm.2022.911234. eCollection 2022.
- Background: PubMed 27832844Fadahunsi OO, Olowoyeye A, Ukaigwe A, Li Z, Vora AN, Vemulapalli S, Elgin E, Donato A. Incidence, Predictors, and Outcomes of Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2189-2199. doi: 10.1016/j.jcin.2016.07.026.
- Individual participant dataSharing planned: No
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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.
Tomasz Soral, MD contact
Krzysztof S. Gołba, MD PhD study chair
Silesian Medical University in Katowice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conduction system pacing and right ventricular or biventricular pacing in people with Atrioventricular Block, Second and Third Degree, run by Medical University of Silesia at 1 site in Poland.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 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 1 site in Poland. 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?
Contact Krzysztof S. Gołba, MD PhD (+48 (32)359-88-93, krzysztof.golba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Failure Hospitalization (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966675, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.