Persistent Atrial FibrillationPeAF-by-LAWTNCT05396534
Personalized Persistent Atrial Fibrillation Ablation: The PeAF-by-LAWT Trial
A study testing Atrial Fibrillation transcatheter ablation in people with Persistent Atrial Fibrillation and Persistent Atrial Fibrillation Longstanding, run by Centro Medico Teknon at 1 site in Spain.
Trial summary
The investigators hypothesized that PeAF-by-LAWT, a personalized protocol that uses a contact-force catheter, a multichannel radiofrequency (RF) generator, and integrated LAWT information to adapt the ablation index (AI) target to the subjacent LAWT, is safe, while showing at least the same efficacy and better… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation, Persistent Atrial Fibrillation Longstanding
- What is being tested?
- Atrial Fibrillation transcatheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
- Indication for persistent atrial fibrillation ablation.
- Signed informed consent
Who cannot join
- Age < 18 years.
- Pregnancy.
- Previous AF redo procedure.
- Impossibility to perform a pre-procedural CT scan.
- Concomitant investigation treatments.
- Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Teknon Medical Center
Barcelona, 08022
Antonio Berruezo, MD, PhD, 669761263 ext. +34, antonio.berruezo@quironsalud.es
About this study
Official title: Personalized Persistent Atrial Fibrillation Ablation: The PeAF-BY-LAWT Trial
The investigators hypothesized that PeAF-by-LAWT, a personalized protocol that uses a contact-force catheter, a multichannel radiofrequency (RF) generator, and integrated LAWT information to adapt the ablation index (AI) target to the subjacent LAWT, is safe, while showing at least the same efficacy and better efficiency than the CLOSE protocol for persistent AF ablation.
Read the detailed description
Pulmonary vein isolation (PVI) remains the cornerstone of all catheter-based treatment strategies in atrial fibrillation (AF). Currently, PVI is recommended (class IA indication) after one failed or intolerant class I or III antiarrhythmic drug (AAD) to improve symptoms, either in paroxysmal (PaAF) or persistent AF (PeAF). However, PVI can be also considered as first-line treatment to achieve rhythm control, particularly in cases when tachycardia-induced cardiomyopathy is suspected, a circumstance likely more related to a higher AF burden or PeAF.
PVI has been proven to be effective in treating PeAF, although long-term ablation outcomes have been significantly less satisfactory than in PaAF. In a recent metaanalysis, PVI in PeAF achieved an arrhythmia-free survival at 12 months of 66.7%, with > 80% of the patients off AAD. Other ablation strategies combining PVI plus additional substrate ablation (linear ablation and/or complex fractionated atrial electrogram ablation) have been unable to demonstrate better outcomes than PVI-alone.
On the other hand, recent advances both in technology and ablation protocols have resulted in greatly improved outcomes after PVI. The introduction of contact force-sensing catheters, novel estimates of lesion size [ablation index (AI) or lesion size index, and the fact of ensuring lesion contiguity (≤ 6 mm inter-lesion distance) have markedly improved arrhythmia-free survival after PVI, particularly in PaAF.
The CLOSE clinical study analyzed the utility of ablation index (AI), a novel formula developed to assess real-time effect of RF delivery and improve the rates of PVI, with 91.3% of the patients free from AF/AT/atrial flutter (AFL) at 12 months follow-up. The CLOSE protocol targeted an interlesion distance (ILD) of 6 mm and AI ≥ 400 at the posterior wall and ≥550 at the anterior wall. Recently, Hussein et al. demonstrated that the use of AI-guided PVI alone performed with radiofrequency energy in a point-by-point wide area circumferential ablation (WACA) pattern according to CLOSE protocol achieves good clinical outcomes in persistent AF patients at 12 months follow-up. Finally, a more recent, personalized PVI strategy, aiming for contiguous lesions with AI titration according to the local left atrial wall thickness (LAWT) as per multidetector cardiac tomography (MDCT), has demonstrated to achieve an arrhythmia-free survival > 95% at 12 months in PaAF.
Up to date, there are no randomized studies for persistent AF ablation comparing the outcomes of PVI-alone procedures performed with a personalized ablation protocol that uses the information of left atrial wall thickness (LAWT), compared with the CLOSE protocol.
The investigators hypothesized that PeAF-by-LAWT, a personalized protocol that uses a contact-force catheter, a multichannel radiofrequency (RF) generator, and integrated LAWT information to adapt the ablation index (AI) target to the subjacent LAWT, is safe, while showing at least the same efficacy and better efficiency than the CLOSE protocol for persistent AF ablation.
This is a two-arm, single-blind, single-center, randomized controlled trial. The study will be conducted in a tertiary hospital with an electrophysiology team of qualified investigators with proven experience in performing atrial fibrillation ablation.
- Being tested
- Atrial Fibrillation transcatheter ablation
- Keywords
- Atrial Fibrillation, Catheter Ablation, Multidetector Computed Tomography, Persistent Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial Fibrillation transcatheter ablationProcedure or surgery
We perform pulmonary veins isolation that remains remains the cornerstone of all catheter-based treatment strategies in atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| byLAWT arm | Experimental | Personalized protocol that uses a contact-force catheter, a multichannel radiofrequency generator, and integrated MDCT-derived Left Atrial Wall Thickness (LAWT) information to adapt the ablation index target to the subjacent LAWT. Receives: Procedure: Atrial Fibrillation transcatheter ablation |
| CLOSE arm | Active comparator | In the CLOSE arm, the use of MDCT-derived LAWT information will not be available for the operator. We uses a contact-force catheter. Ablation will be performed according to the CLOSE study settings: Power-controlled mode (without ramping) with 25 to 35 W (irrigation flow 30 ml/min). RF will be delivered until an AI of 400 at the posterior wall/roof an 550 at the anterior wall are reached. Receives: Procedure: Atrial Fibrillation transcatheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia-free survival
The efficacy primary endpoint will be survival free of any atrial arrhythmia at12-month follow-up visits. From this endpoint, important definitions must be taken into account: AF clinical recurrence will be considered only after the 3-month 'blanking period'.
Measured: After the 3-month 'blanking period' for 12 month
Secondary outcomes (3)
Procedure time
Reduction of procedure time in the byLAWT arm
Measured: intraprocedural outcome
Radiofrequency time
Reduction of radiofrequency time in the byLAWT arm
Measured: intraprocedural outcome
Number of application
Reduction of the number of application in the byLAWT arm
Measured: intraprocedural outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jul 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, single-blind, single-center, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396534
- Sponsor's protocol ID
- PeAF-by-LAWT
- Acronym
- PeAF-by-LAWT
- Status last verified
- Aug 2023
- First submitted
- 25 May 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Teres C, Soto-Iglesias D, Penela D, Jauregui B, Ordonez A, Chauca A, Carreno JM, Scherer C, San Antonio R, Huguet M, Roque A, Ramirez C, Oller G, Jornet A, Palet J, Santana D, Panaro A, Maldonado G, de Leon G, Jimenez G, Evangelista A, Carballo J, Ortiz-Perez JT, Berruezo A. Personalized paroxysmal atrial fibrillation ablation by tailoring ablation index to the left atrial wall thickness: the 'Ablate by-LAW' single-centre study-a pilot study. Europace. 2022 Mar 2;24(3):390-399. doi: 10.1093/europace/euab216.
PubMed 34480548Duytschaever M, De Pooter J, Demolder A, El Haddad M, Phlips T, Strisciuglio T, Debonnaire P, Wolf M, Vandekerckhove Y, Knecht S, Tavernier R. Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: The CLOSE to CURE study. Heart Rhythm. 2020 Apr;17(4):535-543. doi: 10.1016/j.hrthm.2019.11.004. Epub 2019 Nov 9.
PubMed 31707159Taghji P, El Haddad M, Phlips T, Wolf M, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Evaluation of a Strategy Aiming to Enclose the Pulmonary Veins With Contiguous and Optimized Radiofrequency Lesions in Paroxysmal Atrial Fibrillation: A Pilot Study. JACC Clin Electrophysiol. 2018 Jan;4(1):99-108. doi: 10.1016/j.jacep.2017.06.023. Epub 2017 Sep 27.
PubMed 29600792Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.
PubMed 30354288Falasconi G, Penela D, Soto-Iglesias D, Latini AC, Landra F, Curti E, Francia P, Saglietto A, Turturiello D, Viveros D, Bellido A, Alderete J, Zaraket F, Franco-Ocana P, Valcher S, Amata F, Valeriano C, Gigante C, Teresi L, Tonello B, Mea R, Sanchez-Molla L, De Lucia C, Huguet M, Camara O, Ortiz-Perez JT, Marti-Almor J, Berruezo A. Personalized pulmonary vein isolation guided by left atrial wall thickness for persistent atrial fibrillation ablation: the PeAF-by-LAWT randomized trial. Europace. 2025 Dec 1;27(12):euaf163. doi: 10.1093/europace/euaf163.
PubMed 40794635Falasconi G, Penela D, Soto-Iglesias D, Francia P, Teres C, Saglietto A, Jauregui B, Viveros D, Bellido A, Alderete J, Meca-Santamaria J, Franco P, Gaspardone C, San Antonio R, Huguet M, Camara O, Ortiz-Perez JT, Marti-Almor J, Berruezo A. Personalized pulmonary vein antrum isolation guided by left atrial wall thickness for persistent atrial fibrillation. Europace. 2023 May 19;25(5):euad118. doi: 10.1093/europace/euad118.
PubMed 37125968
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Persistent Atrial Fibrillation Ablation: The PeAF-BY-LAWT Trial
- ClinicalTrials.gov ID
- NCT05396534
- Acronym / sponsor ID
- PeAF-by-LAWT / PeAF-by-LAWT
- Keywords
- Atrial Fibrillation, Catheter Ablation, Multidetector Computed Tomography, Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 31 May 2022 (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 investigators hypothesized that PeAF-by-LAWT, a personalized protocol that uses a contact-force catheter, a multichannel radiofrequency (RF) generator, and integrated LAWT information to adapt the ablation index (AI) target to the subjacent LAWT, is safe, while showing at least the same efficacy and better efficiency than the CLOSE protocol for persistent AF ablation.
Detailed description
Pulmonary vein isolation (PVI) remains the cornerstone of all catheter-based treatment strategies in atrial fibrillation (AF). Currently, PVI is recommended (class IA indication) after one failed or intolerant class I or III antiarrhythmic drug (AAD) to improve symptoms, either in paroxysmal (PaAF) or persistent AF (PeAF). However, PVI can be also considered as first-line treatment to achieve rhythm control, particularly in cases when tachycardia-induced cardiomyopathy is suspected, a circumstance likely more related to a higher AF burden or PeAF.
PVI has been proven to be effective in treating PeAF, although long-term ablation outcomes have been significantly less satisfactory than in PaAF. In a recent metaanalysis, PVI in PeAF achieved an arrhythmia-free survival at 12 months of 66.7%, with > 80% of the patients off AAD. Other ablation strategies combining PVI plus additional substrate ablation (linear ablation and/or complex fractionated atrial electrogram ablation) have been unable to demonstrate better outcomes than PVI-alone.
On the other hand, recent advances both in technology and ablation protocols have resulted in greatly improved outcomes after PVI. The introduction of contact force-sensing catheters, novel estimates of lesion size [ablation index (AI) or lesion size index, and the fact of ensuring lesion contiguity (≤ 6 mm inter-lesion distance) have markedly improved arrhythmia-free survival after PVI, particularly in PaAF.
The CLOSE clinical study analyzed the utility of ablation index (AI), a novel formula developed to assess real-time effect of RF delivery and improve the rates of PVI, with 91.3% of the patients free from AF/AT/atrial flutter (AFL) at 12 months follow-up. The CLOSE protocol targeted an interlesion distance (ILD) of 6 mm and AI ≥ 400 at the posterior wall and ≥550 at the anterior wall. Recently, Hussein et al. demonstrated that the use of AI-guided PVI alone performed with radiofrequency energy in a point-by-point wide area circumferential ablation (WACA) pattern according to CLOSE protocol achieves good clinical outcomes in persistent AF patients at 12 months follow-up. Finally, a more recent, personalized PVI strategy, aiming for contiguous lesions with AI titration according to the local left atrial wall thickness (LAWT) as per multidetector cardiac tomography (MDCT), has demonstrated to achieve an arrhythmia-free survival > 95% at 12 months in PaAF.
Up to date, there are no randomized studies for persistent AF ablation comparing the outcomes of PVI-alone procedures performed with a personalized ablation protocol that uses the information of left atrial wall thickness (LAWT), compared with the CLOSE protocol.
The investigators hypothesized that PeAF-by-LAWT, a personalized protocol that uses a contact-force catheter, a multichannel radiofrequency (RF) generator, and integrated LAWT information to adapt the ablation index (AI) target to the subjacent LAWT, is safe, while showing at least the same efficacy and better efficiency than the CLOSE protocol for persistent AF ablation.
This is a two-arm, single-blind, single-center, randomized controlled trial. The study will be conducted in a tertiary hospital with an electrophysiology team of qualified investigators with proven experience in performing atrial fibrillation ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Two-arm, single-blind, single-center, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| byLAWT arm | Experimental | Procedure: Atrial Fibrillation transcatheter ablationPersonalized protocol that uses a contact-force catheter, a multichannel radiofrequency generator, and integrated MDCT-derived Left Atrial Wall Thickness (LAWT) information to adapt the ablation index target to the subjacent LAWT. |
| CLOSE arm | Active comparator | Procedure: Atrial Fibrillation transcatheter ablationIn the CLOSE arm, the use of MDCT-derived LAWT information will not be available for the operator. We uses a contact-force catheter. Ablation will be performed according to the CLOSE study settings: Power-controlled mode (without ramping) with 25 to 35 W (irrigation flow 30 ml/min). RF will be delivered until an AI of 400 at the posterior wall/roof an 550 at the anterior wall are reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years.
- Indication for persistent atrial fibrillation ablation.
- Signed informed consent
Key exclusion criteria (6 listed)
- Age < 18 years.
- Pregnancy.
- Previous AF redo procedure.
- Impossibility to perform a pre-procedural CT scan.
- Concomitant investigation treatments.
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 |
|---|---|---|
| Atrial Fibrillation transcatheter ablationWe perform pulmonary veins isolation that remains remains the cornerstone of all catheter-based treatment strategies in atrial fibrillation | Procedure or surgery | CLOSE arm, byLAWT arm |
Primary outcome
Arrhythmia-free survival
Time frame: After the 3-month 'blanking period' for 12 month
The efficacy primary endpoint will be survival free of any atrial arrhythmia at12-month follow-up visits. From this endpoint, important definitions must be taken into account: AF clinical recurrence will be considered only after the 3-month 'blanking period'.
3 secondary outcomes
Procedure time
Time frame: intraprocedural outcome
Radiofrequency time
Time frame: intraprocedural outcome
Number of application
Time frame: intraprocedural outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Results publication: PubMed 34480548Teres C, Soto-Iglesias D, Penela D, Jauregui B, Ordonez A, Chauca A, Carreno JM, Scherer C, San Antonio R, Huguet M, Roque A, Ramirez C, Oller G, Jornet A, Palet J, Santana D, Panaro A, Maldonado G, de Leon G, Jimenez G, Evangelista A, Carballo J, Ortiz-Perez JT, Berruezo A. Personalized paroxysmal atrial fibrillation ablation by tailoring ablation index to the left atrial wall thickness: the 'Ablate by-LAW' single-centre study-a pilot study. Europace. 2022 Mar 2;24(3):390-399. doi: 10.1093/europace/euab216.
- Results publication: PubMed 31707159Duytschaever M, De Pooter J, Demolder A, El Haddad M, Phlips T, Strisciuglio T, Debonnaire P, Wolf M, Vandekerckhove Y, Knecht S, Tavernier R. Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: The CLOSE to CURE study. Heart Rhythm. 2020 Apr;17(4):535-543. doi: 10.1016/j.hrthm.2019.11.004. Epub 2019 Nov 9.
- Results publication: PubMed 29600792Taghji P, El Haddad M, Phlips T, Wolf M, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Evaluation of a Strategy Aiming to Enclose the Pulmonary Veins With Contiguous and Optimized Radiofrequency Lesions in Paroxysmal Atrial Fibrillation: A Pilot Study. JACC Clin Electrophysiol. 2018 Jan;4(1):99-108. doi: 10.1016/j.jacep.2017.06.023. Epub 2017 Sep 27.
- Results publication: PubMed 30354288Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.
- Derived from this study: PubMed 40794635Falasconi G, Penela D, Soto-Iglesias D, Latini AC, Landra F, Curti E, Francia P, Saglietto A, Turturiello D, Viveros D, Bellido A, Alderete J, Zaraket F, Franco-Ocana P, Valcher S, Amata F, Valeriano C, Gigante C, Teresi L, Tonello B, Mea R, Sanchez-Molla L, De Lucia C, Huguet M, Camara O, Ortiz-Perez JT, Marti-Almor J, Berruezo A. Personalized pulmonary vein isolation guided by left atrial wall thickness for persistent atrial fibrillation ablation: the PeAF-by-LAWT randomized trial. Europace. 2025 Dec 1;27(12):euaf163. doi: 10.1093/europace/euaf163.
- Derived from this study: PubMed 37125968Falasconi G, Penela D, Soto-Iglesias D, Francia P, Teres C, Saglietto A, Jauregui B, Viveros D, Bellido A, Alderete J, Meca-Santamaria J, Franco P, Gaspardone C, San Antonio R, Huguet M, Camara O, Ortiz-Perez JT, Marti-Almor J, Berruezo A. Personalized pulmonary vein antrum isolation guided by left atrial wall thickness for persistent atrial fibrillation. Europace. 2023 May 19;25(5):euad118. doi: 10.1093/europace/euad118.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial Fibrillation transcatheter ablation in people with Persistent Atrial Fibrillation and Persistent Atrial Fibrillation Longstanding, run by Centro Medico Teknon at 1 site in Spain.
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 6 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Berruezo, MD, PhD (669761263 ext. +34, antonio.berruezo@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia-free survival (time frame: After the 3-month 'blanking period' for 12 month). 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 NCT05396534, which also lists 6 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 30 Aug 2023.