Aortic StenosisTAVI-PACENCT05889208
Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
A study testing Prophylactic pacemaker implantation in people with Aortic Stenosis and Right Bundle-Branch Block, run by Aalborg University Hospital.
Trial summary
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients with severe aortic stenosis and left ventricular ejection fraction.Participants will be… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Stenosis, Right Bundle-Branch Block
- What is being tested?
- Prophylactic pacemaker implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2027
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients undergoing TAVI indicated by severe valvular aortic stenosis
- Written informed consent
- Left ventricular ejection fraction ≥ 40 %
- Persistent RBBB in 12-lead electrocardiogram (RSR' pattern in V1-3, QRS duration > 120 milliseconds, and wide S wave in leads I, aVL, V5-6)
Who cannot join
- Other indications for pacemaker implantation or previously implanted pacemaker
- Life expectancy < 1 year
- No written informed consent
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
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients with severe aortic stenosis and left ventricular ejection fraction.Participants will be randomized to:
- Prophylactic pacemaker implantation prior TAVI
- Conservative strategy
Read the detailed description
BACKGROUND Transcatheter aortic valve implantation (TAVI) is standard of care treatment for patients with severe aortic stenosis ≥ 75 years and/or not eligible for surgical aortic valve replacement 1. There are two types of prosthetic valves: balloon expandable (BE) and self-expandable (SE) types with their distinct features 2. The TAVI-procedure and preexisting conditions in this population entails a risk of permanent pacemaker implantation following TAVI due to conduction disturbances related to the valve implantation and valve type (BE vs. SE). The rate of permanent pacemaker implantation after TAVI is between 2.3 - 36 % depending on valve type and pre-existing conditions3. Major risk factors are right bundle branch block (RBBB), left ventricular outflow track calcification, deeper valve implantation, and SE valves4. Pre-existing RBBB in patients undergoing TAVI occurs in 10% of the cases and it is associated with poor outcome5 in terms of higher pacemaker rate and mortality. Advanced conduction disturbances in patients with pre-existing RBBB occur within three days after the TAVI-procedure6. Hence, pre-existing RBBB is a major risk factor in the TAVI-population with higher mortality7 and needs special attention in peri-operative care. Current European Society Cardiology guidelines do not recommend prophylactic pacemaker implantation in patients without indication for permanent pacing8. However, cardiac pacing is associated with a risk of complications and development of heart failure9, and there is no randomized trial demonstrating a benefit of prophylactic pacemaker implantation in patients with pre-existing RBBB. Although previous observational data suggest prophylactic pacemaker implantation in patients with pre-existing RBBB shortens the TAVI procedure and prevents rehospitalization due to heart block10. Hence, there is a gap in knowledge regarding the outcome of prophylactic permanent pacemaker implantation in patients undergoing TAVI with pre-procedural RBBB and additional risk factors for need of post-procedural permanent pacing. This study aims to evaluate the clinical outcome and safety of prophylactic pacemaker implantation in this high-risk patient group versus a conservative strategy in a randomized clinical trial.
PURPOSE To evaluate safety and outcomes of prophylactic permanent pacemaker implantation in patients with RBBB undergoing TAVI.
HYPOTHESIS Prophylactic permanent pacemaker implantation reduces composite primary outcome in patients with RBBB undergoing TAVI.
- Conditions
- Aortic Stenosis, Right Bundle-Branch Block
- Being tested
- Prophylactic pacemaker implantation
- Keywords
- Trans-catheter aortic valve implantation, Pacemaker
- Medical subject headings
- Aortic Valve Stenosis, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic pacemaker implantationDevice
Pacemaker implantation prior the TAVI-procedure
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic pacemaker implantation | Active comparator | Brady-pacemaker implantation prior the TAVI-procedure. Pacemaker modus is according to local conditions. Receives: Device: Prophylactic pacemaker implantation |
| Usual care | No intervention | Pacemaker implantation after TAVI if atrioventricular block occurs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Events in the control arm
Composite of all-cause mortality, unplanned pacemaker implantation and new onset of heart failure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies 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
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashkan Eftekhari, Aalborg University Hospital
- Investigators
- Ashkan Eftekhari, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889208
- Sponsor's protocol ID
- TAVI-PACE
- Acronym
- TAVI-PACE
- Status last verified
- May 2023
- First submitted
- 26 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
PubMed 34453165Suh SH, Oh TR, Choi HS, Yang EM, Kim CS, Bae EH, Ma SK, Oh KH, Hyun YY, Sung S, Kim SW; Korean Cohort Study for Outcomes in Patients with Chronic Kidney Disease (KNOW-CKD) Investigators. Bone Mineral Density and All-Cause Mortality in Patients with Nondialysis Chronic Kidney Disease: Results from KNOW-CKD Study. J Clin Med. 2023 Feb 25;12(5):1850. doi: 10.3390/jcm12051850.
PubMed 36902637van Rosendael PJ, Delgado V, Bax JJ. Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review. Eur Heart J. 2018 Jun 1;39(21):2003-2013. doi: 10.1093/eurheartj/ehx785.
PubMed 29420704Maeno Y, Abramowitz Y, Kawamori H, Kazuno Y, Kubo S, Takahashi N, Mangat G, Okuyama K, Kashif M, Chakravarty T, Nakamura M, Cheng W, Friedman J, Berman D, Makkar RR, Jilaihawi H. A Highly Predictive Risk Model for Pacemaker Implantation After TAVR. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1139-1147. doi: 10.1016/j.jcmg.2016.11.020. Epub 2017 Apr 12.
PubMed 28412434Auffret V, Webb JG, Eltchaninoff H, Munoz-Garcia AJ, Himbert D, Tamburino C, Nombela-Franco L, Nietlispach F, Moris C, Ruel M, Dager AE, Serra V, Cheema AN, Amat-Santos IJ, de Brito FS Jr, Lemos PA, Abizaid A, Sarmento-Leite R, Dumont E, Barbanti M, Durand E, Alonso Briales JH, Vahanian A, Bouleti C, Imme S, Maisano F, Del Valle R, Benitez LM, Garcia Del Blanco B, Puri R, Philippon F, Urena M, Rodes-Cabau J. Clinical Impact of Baseline Right Bundle Branch Block in Patients Undergoing Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2017 Aug 14;10(15):1564-1574. doi: 10.1016/j.jcin.2017.05.030. Epub 2017 Jul 19.
PubMed 28734885Watanabe Y, Kozuma K, Hioki H, Kawashima H, Nara Y, Kataoka A, Nagura F, Nakashima M, Shirai S, Tada N, Araki M, Takagi K, Yamanaka F, Yamamoto M, Hayashida K. Pre-Existing Right Bundle Branch Block Increases Risk for Death After Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2210-2216. doi: 10.1016/j.jcin.2016.08.035.
PubMed 27832846Glikson 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 34455430Nielsen JC, Andersen HR, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Heart failure and echocardiographic changes during long-term follow-up of patients with sick sinus syndrome randomized to single-chamber atrial or ventricular pacing. Circulation. 1998 Mar 17;97(10):987-95. doi: 10.1161/01.cir.97.10.987.
PubMed 9529267Okuno T, Asami M, Heg D, Lanz J, Praz F, Hagemeyer D, Brugger N, Grani C, Huber A, Spirito A, Raber L, Stortecky S, Windecker S, Pilgrim T. Impact of Left Ventricular Outflow Tract Calcification on Procedural Outcomes After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Aug 10;13(15):1789-1799. doi: 10.1016/j.jcin.2020.04.015.
PubMed 32763071Bisson A, Bodin A, Herbert J, Lacour T, Saint Etienne C, Pierre B, Clementy N, Deharo P, Babuty D, Fauchier L. Pacemaker Implantation After Balloon- or Self-Expandable Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis. J Am Heart Assoc. 2020 May 5;9(9):e015896. doi: 10.1161/JAHA.120.015896. Epub 2020 May 2.
PubMed 32362220
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05889208
- Acronym / sponsor ID
- TAVI-PACE / TAVI-PACE
- Conditions
- Aortic Stenosis, Right Bundle-Branch Block
- Keywords
- Trans-catheter aortic valve implantation, Pacemaker
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Jun 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 goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients with severe aortic stenosis and left ventricular ejection fraction.Participants will be randomized to:
- Prophylactic pacemaker implantation prior TAVI
- Conservative strategy
Detailed description
BACKGROUND Transcatheter aortic valve implantation (TAVI) is standard of care treatment for patients with severe aortic stenosis ≥ 75 years and/or not eligible for surgical aortic valve replacement 1. There are two types of prosthetic valves: balloon expandable (BE) and self-expandable (SE) types with their distinct features 2. The TAVI-procedure and preexisting conditions in this population entails a risk of permanent pacemaker implantation following TAVI due to conduction disturbances related to the valve implantation and valve type (BE vs. SE). The rate of permanent pacemaker implantation after TAVI is between 2.3 - 36 % depending on valve type and pre-existing conditions3. Major risk factors are right bundle branch block (RBBB), left ventricular outflow track calcification, deeper valve implantation, and SE valves4. Pre-existing RBBB in patients undergoing TAVI occurs in 10% of the cases and it is associated with poor outcome5 in terms of higher pacemaker rate and mortality. Advanced conduction disturbances in patients with pre-existing RBBB occur within three days after the TAVI-procedure6. Hence, pre-existing RBBB is a major risk factor in the TAVI-population with higher mortality7 and needs special attention in peri-operative care. Current European Society Cardiology guidelines do not recommend prophylactic pacemaker implantation in patients without indication for permanent pacing8. However, cardiac pacing is associated with a risk of complications and development of heart failure9, and there is no randomized trial demonstrating a benefit of prophylactic pacemaker implantation in patients with pre-existing RBBB. Although previous observational data suggest prophylactic pacemaker implantation in patients with pre-existing RBBB shortens the TAVI procedure and prevents rehospitalization due to heart block10. Hence, there is a gap in knowledge regarding the outcome of prophylactic permanent pacemaker implantation in patients undergoing TAVI with pre-procedural RBBB and additional risk factors for need of post-procedural permanent pacing. This study aims to evaluate the clinical outcome and safety of prophylactic pacemaker implantation in this high-risk patient group versus a conservative strategy in a randomized clinical trial.
PURPOSE To evaluate safety and outcomes of prophylactic permanent pacemaker implantation in patients with RBBB undergoing TAVI.
HYPOTHESIS Prophylactic permanent pacemaker implantation reduces composite primary outcome in patients with RBBB undergoing TAVI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic pacemaker implantation | Active comparator | Device: Prophylactic pacemaker implantationBrady-pacemaker implantation prior the TAVI-procedure. Pacemaker modus is according to local conditions. |
| Usual care | No intervention | –Pacemaker implantation after TAVI if atrioventricular block occurs. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients undergoing TAVI indicated by severe valvular aortic stenosis
- Written informed consent
- Left ventricular ejection fraction ≥ 40 %
- Persistent RBBB in 12-lead electrocardiogram (RSR' pattern in V1-3, QRS duration > 120 milliseconds, and wide S wave in leads I, aVL, V5-6)
Key exclusion criteria (3 listed)
- Other indications for pacemaker implantation or previously implanted pacemaker
- Life expectancy < 1 year
- No written informed consent
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 |
|---|---|---|
| Prophylactic pacemaker implantationPacemaker implantation prior the TAVI-procedure | Device | Prophylactic pacemaker implantation |
Primary outcome
Events in the control arm
Time frame: 12 months
Composite of all-cause mortality, unplanned pacemaker implantation and new onset of heart failure
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 5 Jun 2023.
- Background: PubMed 34453165Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
- Background: PubMed 36902637Suh SH, Oh TR, Choi HS, Yang EM, Kim CS, Bae EH, Ma SK, Oh KH, Hyun YY, Sung S, Kim SW; Korean Cohort Study for Outcomes in Patients with Chronic Kidney Disease (KNOW-CKD) Investigators. Bone Mineral Density and All-Cause Mortality in Patients with Nondialysis Chronic Kidney Disease: Results from KNOW-CKD Study. J Clin Med. 2023 Feb 25;12(5):1850. doi: 10.3390/jcm12051850.
- Background: PubMed 29420704van Rosendael PJ, Delgado V, Bax JJ. Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review. Eur Heart J. 2018 Jun 1;39(21):2003-2013. doi: 10.1093/eurheartj/ehx785.
- Background: PubMed 28412434Maeno Y, Abramowitz Y, Kawamori H, Kazuno Y, Kubo S, Takahashi N, Mangat G, Okuyama K, Kashif M, Chakravarty T, Nakamura M, Cheng W, Friedman J, Berman D, Makkar RR, Jilaihawi H. A Highly Predictive Risk Model for Pacemaker Implantation After TAVR. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1139-1147. doi: 10.1016/j.jcmg.2016.11.020. Epub 2017 Apr 12.
- Background: PubMed 28734885Auffret V, Webb JG, Eltchaninoff H, Munoz-Garcia AJ, Himbert D, Tamburino C, Nombela-Franco L, Nietlispach F, Moris C, Ruel M, Dager AE, Serra V, Cheema AN, Amat-Santos IJ, de Brito FS Jr, Lemos PA, Abizaid A, Sarmento-Leite R, Dumont E, Barbanti M, Durand E, Alonso Briales JH, Vahanian A, Bouleti C, Imme S, Maisano F, Del Valle R, Benitez LM, Garcia Del Blanco B, Puri R, Philippon F, Urena M, Rodes-Cabau J. Clinical Impact of Baseline Right Bundle Branch Block in Patients Undergoing Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2017 Aug 14;10(15):1564-1574. doi: 10.1016/j.jcin.2017.05.030. Epub 2017 Jul 19.
- Background: PubMed 27832846Watanabe Y, Kozuma K, Hioki H, Kawashima H, Nara Y, Kataoka A, Nagura F, Nakashima M, Shirai S, Tada N, Araki M, Takagi K, Yamanaka F, Yamamoto M, Hayashida K. Pre-Existing Right Bundle Branch Block Increases Risk for Death After Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2210-2216. doi: 10.1016/j.jcin.2016.08.035.
- 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 9529267Nielsen JC, Andersen HR, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Heart failure and echocardiographic changes during long-term follow-up of patients with sick sinus syndrome randomized to single-chamber atrial or ventricular pacing. Circulation. 1998 Mar 17;97(10):987-95. doi: 10.1161/01.cir.97.10.987.
- Background: PubMed 32763071Okuno T, Asami M, Heg D, Lanz J, Praz F, Hagemeyer D, Brugger N, Grani C, Huber A, Spirito A, Raber L, Stortecky S, Windecker S, Pilgrim T. Impact of Left Ventricular Outflow Tract Calcification on Procedural Outcomes After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Aug 10;13(15):1789-1799. doi: 10.1016/j.jcin.2020.04.015.
- Background: PubMed 32362220Bisson A, Bodin A, Herbert J, Lacour T, Saint Etienne C, Pierre B, Clementy N, Deharo P, Babuty D, Fauchier L. Pacemaker Implantation After Balloon- or Self-Expandable Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis. J Am Heart Assoc. 2020 May 5;9(9):e015896. doi: 10.1161/JAHA.120.015896. Epub 2020 May 2.
- Individual participant dataSharing planned: Yes
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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.
Ashkan Eftekhari principal investigator
Aalborg University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic pacemaker implantation in people with Aortic Stenosis and Right Bundle-Branch Block, run by Aalborg 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 4 inclusion and 3 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 5 Jun 2023. 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 Ashkan Eftekhari, MD PhD (+4597664465, asef@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Events in the control arm (time frame: 12 months). 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 NCT05889208, which also lists 10 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 5 Jun 2023.