Coronary Artery BypassPhase 4NCT02731794
On-pump Beating Coronary Artery Bypass Grafting by Ventricular Assist
A Phase 4 study testing left ventricular assist and Biventricular assist in people with Coronary Artery Bypass, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
The investigators designed the randomized prospective study to evaluate the differences of inflammatory response and clinical outcome after on-pump beating coronary artery bypass grafting undergoing left ventricular assist versus biventricular assist in patients with severe left ventricle dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- left ventricular assist and Biventricular assist
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Oct 2023
- Phase
- Phase 4
- 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
- patients with severe left ventricle dysfunction with an ejection fraction (EF)≤40%, being scheduled for revascularization.
Who cannot join
- myocardial infarction within the preceding 4 weeks
- severe valve disease requiring valve replacement
- cardiac reoperations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Response and Clinical Outcome After On-pump Beating Coronary Artery Bypass Grafting Using Left Ventricular Assist Versus Biventricular Assist in Patients With Severe Left Ventricle Dysfunction
The investigators designed the randomized prospective study to evaluate the differences of inflammatory response and clinical outcome after on-pump beating coronary artery bypass grafting undergoing left ventricular assist versus biventricular assist in patients with severe left ventricle dysfunction.
Read the detailed description
Off-pump coronary artery bypass grafting (CABG) tends to have a lower incidence of postoperative complications and remarkable advantages in terms of hospital stay. However, some drawbacks include higher rates of incomplete revascularization and the hemodynamic deterioration during manipulation of the heart, more occurring in the cases of posterolateral anatomical constraints and cardiac dysfunction. It leads to urgent conversion to extracorporeal circulation (ECC) and increases the mortality. Although conventional ECC with cardioplegia arrest provides bloodless immovable field, intense systemic inflammatory response may contribute to hemodynamic unstability especially in patients already with severe cardiac dysfunction.
On-pump beating CABG, as a more comprehensive approach, not only facilitates stable hemodynamics and complete revascularization, but also supports myocardial lymphatic flow balance and decreases interstitial myocardial edema in the beating state. Especially in the high-risk patients,some findings suggested that off-pump CABG should be converted to on-pump beating CABG without hesitation, avoiding hemodynamic collapse and even catastrophic outcomes. Some investigators intentionally planned on-pump beating CABG aiming to some patients with severe left ventricle dysfunction. Furthermore, on-pump beating CABG with ECC assistance in a high-risk subgroup is also an acceptable trade-off between conventional cardioplegia and off-pump operations.
The above-mentioned ECC results about on-pump, beating-heart CABG pay much attention to the biventricular assist (BiVA). Nonetheless, much evidence also reveals that BiVA triggers an intense inflammatory response due to extracorporeal membrane lung and circuit line. Comparatively speaking, single left ventricular assist (LVA), with shorter circuit line, less priming volume and free of extracorporeal membrane lung, theoretically should reduce the inflammatory response and relative complications. As a result, aiming to the high-risk patients with severe left ventricle dysfunction, who need ECC assistance (BiVA or LVA), the investigators designed the randomized prospective study to evaluate: 1) the differences in myocardial injury as expressed by cardiac Troponin I(cTnI) and in inflammatory response by C-reactive protein (CRP), 2) the differences in the early postoperative outcomes including graft number, incidence of atrial fibrillation, in-hospital mortality and ICU stay.
- Conditions
- Coronary Artery Bypass
- Being tested
- left ventricular assist, Biventricular assist
- Keywords
- cardiopulmonary bypass, coronary artery bypass grafting, inflammatory response, cardiac dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left ventricular assistDevice
In left ventricular assist group, 100 IU/kg heparin was given to activated clotting time (ACT) greater than 180 seconds. A 22 French arterial cannula (Maquet, Irrlingen, Germany) was introduced into the ascending aorta, and a 26 French cannula (Eurosets, Medolla, Italy) into the left atrium and advanced into the left ventricle. The two cannulas are directly connected through a short, heparin-coated circuit to a centrifuge pump (Maquet, Getinge Group, Germany). A flow of 1.0 to 4.0 L/min/m2 is obtained and mean blood pressure was maintained 55-75 mm Hg. Note: Both LVA group and BiVA group have the operative protocols itself,includes different prime fluid and cannula pathway. The investigators think it is inapplicable to assign the different operative protocols to the Treatment Arm.
Biventricular assistProcedure or surgery
In biventricular assist group, the patients were routinely heparinized with a dose of 300 IU/kg heparin to ACT greater than 480 seconds. Cardiopulmonary bypass with a centrifuge pump (Maquet, Getinge Group, Germany) was established by 22 French aortic cannulation and 34 French two-stage venous cannula through the right atrial appendage. The extracorporeal circuit was primed with 2000 mL of lactated Ringer's solution, albumin, 25% mannitol and 5% NaHCO3. The flow was 1.0 to 4.0 L/min/m2 and mean blood pressure was maintained 55-75 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| LVA group | Experimental | LVA group: left ventricular assist group. Receives: Device: left ventricular assist |
| BiVA group | Active comparator | BiVA group: Biventricular assist group. Receives: Procedure: Biventricular assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of C-reactive protein (CRP)
Serial blood samples for inflammatory response of CRP were collected at the following time points: 1: induction of anesthesia, 2: upon termination of cardiopulmonary bypass (CPB), 3: 6 hours postoperatively, 4: 24 hours postoperatively, 5: 48 hours postoperatively, 6: 72 hours postoperatively.
Measured: up tp 72 hours
Secondary outcomes (6)
Incidence of atrial fibrillation
from ICU admission to discharge
Measured: 10 days
Durations of mechanical ventilation
Measured: 10 days
The number for transfused packed red cells
measured by milliliter from ICU admission to discharge
Measured: up to 10 days
Partial oxygen pressure/inspired oxygen fraction (P/F)
Measured: up tp 10 days
Cardiac Troponin I (cTnI)
Serial blood samples for cTnI were collected at the following time points: 1: induction of anesthesia, 2: upon termination of CPB, 3: 6 hours postoperatively, 4: 24 hours postoperatively, 5: 48 hours postoperatively, 6: 72 hours postoperatively.
Measured: up to72 hours
In-hospital mortality
from ICU admission to discharge
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (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 Coronary Artery BypassStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhao, Henan Institute of Cardiovascular Epidemiology
- Investigators
- Zhaoyun Cheng, MD, Study director, Henan Provincial People' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731794
- Sponsor's protocol ID
- HenanICE201602
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2016
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lim E, Drain A, Davies W, Edmonds L, Rosengard BR. A systematic review of randomized trials comparing revascularization rate and graft patency of off-pump and conventional coronary surgery. J Thorac Cardiovasc Surg. 2006 Dec;132(6):1409-13. doi: 10.1016/j.jtcvs.2006.08.012.
PubMed 17140968Urso S, Sadaba JR, Pettinari M. Impact of off-pump to on-pump conversion rate on post-operative results in patients undergoing off-pump coronary artery bypass. Interact Cardiovasc Thorac Surg. 2012 Feb;14(2):188-93. doi: 10.1093/icvts/ivr071. Epub 2011 Nov 28.
PubMed 22159253Fujii T, Watanabe Y, Shiono N, Kawasaki M, Yokomuro H, Ozawa T, Hamada S, Masuhara H, Teramoto T, Hara M, Katayanagi T, Sasaki Y, Koyama N. Assessment of on-pump beating coronary artery bypass surgery performed after introduction of off-pump approach. Ann Thorac Cardiovasc Surg. 2006 Oct;12(5):324-32.
PubMed 17095974Erkut B, Dag O, Kaygin MA, Senocak M, Limandal HK, Arslan U, Kiymaz A, Aydin A, Kahraman N, Calik ES. On-pump beating-heart versus conventional coronary artery bypass grafting for revascularization in patients with severe left ventricular dysfunction: early outcomes. Can J Surg. 2013 Dec;56(6):398-404. doi: 10.1503/cjs.018412.
PubMed 24284147Mazzei V, Nasso G, Salamone G, Castorino F, Tommasini A, Anselmi A. Prospective randomized comparison of coronary bypass grafting with minimal extracorporeal circulation system (MECC) versus off-pump coronary surgery. Circulation. 2007 Oct 16;116(16):1761-7. doi: 10.1161/CIRCULATIONAHA.107.697482. Epub 2007 Sep 17.
PubMed 17875971Al Jaaly E, Chaudhry UA, Harling L, Athanasiou T. Should we consider beating-heart on-pump coronary artery bypass grafting over conventional cardioplegic arrest to improve postoperative outcomes in selected patients? Interact Cardiovasc Thorac Surg. 2015 Apr;20(4):538-45. doi: 10.1093/icvts/ivu425. Epub 2014 Dec 21.
PubMed 25535178Stassano P, Di Tommaso L, Monaco M, Iesu S, Brando G, Buonpane S, Ambrosio G, Di Benedetto G, Pepino P. Myocardial revascularization by left ventricular assisted beating heart is associated with reduced systemic inflammatory response. Ann Thorac Surg. 2009 Jan;87(1):46-52. doi: 10.1016/j.athoracsur.2008.07.098.
PubMed 19101266Gulcan O, Turkoz R, Turkoz A, Caliskan E, Sezgin AT. On-pump/beating-heart myocardial protection for isolated or combined coronary artery bypass grafting in patients with severe left ventricle dysfunction: assessment of myocardial function and clinical outcome. Heart Surg Forum. 2005;8(3):E178-82; discussion E183. doi: 10.1532/HSF98.20041166.
PubMed 15937002Ferrari E, Stalder N, von Segesser LK. On-pump beating heart coronary surgery for high risk patients requiring emergency multiple coronary artery bypass grafting. J Cardiothorac Surg. 2008 Jul 2;3:38. doi: 10.1186/1749-8090-3-38.
PubMed 18597673Folliguet TA, Philippe F, Larrazet F, Dibie A, Czitrom D, Le Bret E, Bachet J, Laborde F. Beating heart revascularization with minimal extracorporeal circulation in patients with a poor ejection fraction. Heart Surg Forum. 2002;6(1):19-23. doi: 10.1532/hsf.992.
PubMed 12611727
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response and Clinical Outcome After On-pump Beating Coronary Artery Bypass Grafting Using Left Ventricular Assist Versus Biventricular Assist in Patients With Severe Left Ventricle Dysfunction
- ClinicalTrials.gov ID
- NCT02731794
- Acronym / sponsor ID
- HenanICE201602
- Conditions
- Coronary Artery Bypass
- Keywords
- cardiopulmonary bypass, coronary artery bypass grafting, inflammatory response, cardiac dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 8 Apr 2016 (estimated)
- 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 designed the randomized prospective study to evaluate the differences of inflammatory response and clinical outcome after on-pump beating coronary artery bypass grafting undergoing left ventricular assist versus biventricular assist in patients with severe left ventricle dysfunction.
Detailed description
Off-pump coronary artery bypass grafting (CABG) tends to have a lower incidence of postoperative complications and remarkable advantages in terms of hospital stay. However, some drawbacks include higher rates of incomplete revascularization and the hemodynamic deterioration during manipulation of the heart, more occurring in the cases of posterolateral anatomical constraints and cardiac dysfunction. It leads to urgent conversion to extracorporeal circulation (ECC) and increases the mortality. Although conventional ECC with cardioplegia arrest provides bloodless immovable field, intense systemic inflammatory response may contribute to hemodynamic unstability especially in patients already with severe cardiac dysfunction.
On-pump beating CABG, as a more comprehensive approach, not only facilitates stable hemodynamics and complete revascularization, but also supports myocardial lymphatic flow balance and decreases interstitial myocardial edema in the beating state. Especially in the high-risk patients,some findings suggested that off-pump CABG should be converted to on-pump beating CABG without hesitation, avoiding hemodynamic collapse and even catastrophic outcomes. Some investigators intentionally planned on-pump beating CABG aiming to some patients with severe left ventricle dysfunction. Furthermore, on-pump beating CABG with ECC assistance in a high-risk subgroup is also an acceptable trade-off between conventional cardioplegia and off-pump operations.
The above-mentioned ECC results about on-pump, beating-heart CABG pay much attention to the biventricular assist (BiVA). Nonetheless, much evidence also reveals that BiVA triggers an intense inflammatory response due to extracorporeal membrane lung and circuit line. Comparatively speaking, single left ventricular assist (LVA), with shorter circuit line, less priming volume and free of extracorporeal membrane lung, theoretically should reduce the inflammatory response and relative complications. As a result, aiming to the high-risk patients with severe left ventricle dysfunction, who need ECC assistance (BiVA or LVA), the investigators designed the randomized prospective study to evaluate: 1) the differences in myocardial injury as expressed by cardiac Troponin I(cTnI) and in inflammatory response by C-reactive protein (CRP), 2) the differences in the early postoperative outcomes including graft number, incidence of atrial fibrillation, in-hospital mortality and ICU stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVA group | Experimental | Device: left ventricular assistLVA group: left ventricular assist group. |
| BiVA group | Active comparator | Procedure: Biventricular assistBiVA group: Biventricular assist group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with severe left ventricle dysfunction with an ejection fraction (EF)≤40%, being scheduled for revascularization.
Key exclusion criteria (3 listed)
- myocardial infarction within the preceding 4 weeks
- severe valve disease requiring valve replacement
- cardiac reoperations
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 |
|---|---|---|
| left ventricular assistIn left ventricular assist group, 100 IU/kg heparin was given to activated clotting time (ACT) greater than 180 seconds. A 22 French arterial cannula (Maquet, Irrlingen, Germany) was introduced into the ascending aorta, and a 26 French cannula (Eurosets, Medolla, Italy) into the left atrium and advanced into the left ventricle. The two cannulas are directly connected through a short, heparin-coated circuit to a centrifuge pump (Maquet, Getinge Group, Germany). A flow of 1.0 to 4.0 L/min/m2 is obtained and mean blood pressure was maintained 55-75 mm Hg. Note: Both LVA group and BiVA group have the operative protocols itself,includes different prime fluid and cannula pathway. The investigators think it is inapplicable to assign the different operative protocols to the Treatment Arm. | Device | LVA group |
| Biventricular assistIn biventricular assist group, the patients were routinely heparinized with a dose of 300 IU/kg heparin to ACT greater than 480 seconds. Cardiopulmonary bypass with a centrifuge pump (Maquet, Getinge Group, Germany) was established by 22 French aortic cannulation and 34 French two-stage venous cannula through the right atrial appendage. The extracorporeal circuit was primed with 2000 mL of lactated Ringer's solution, albumin, 25% mannitol and 5% NaHCO3. The flow was 1.0 to 4.0 L/min/m2 and mean blood pressure was maintained 55-75 mm Hg. | Procedure or surgery | BiVA group |
Primary outcome
Changes of C-reactive protein (CRP)
Time frame: up tp 72 hours
Serial blood samples for inflammatory response of CRP were collected at the following time points: 1: induction of anesthesia, 2: upon termination of cardiopulmonary bypass (CPB), 3: 6 hours postoperatively, 4: 24 hours postoperatively, 5: 48 hours postoperatively, 6: 72 hours postoperatively.
6 secondary outcomes
Incidence of atrial fibrillation
Time frame: 10 days
Durations of mechanical ventilation
Time frame: 10 days
The number for transfused packed red cells
Time frame: up to 10 days
Partial oxygen pressure/inspired oxygen fraction (P/F)
Time frame: up tp 10 days
Cardiac Troponin I (cTnI)
Time frame: up to72 hours
In-hospital mortality
Time frame: up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Results publication: PubMed 17140968Lim E, Drain A, Davies W, Edmonds L, Rosengard BR. A systematic review of randomized trials comparing revascularization rate and graft patency of off-pump and conventional coronary surgery. J Thorac Cardiovasc Surg. 2006 Dec;132(6):1409-13. doi: 10.1016/j.jtcvs.2006.08.012.
- Results publication: PubMed 22159253Urso S, Sadaba JR, Pettinari M. Impact of off-pump to on-pump conversion rate on post-operative results in patients undergoing off-pump coronary artery bypass. Interact Cardiovasc Thorac Surg. 2012 Feb;14(2):188-93. doi: 10.1093/icvts/ivr071. Epub 2011 Nov 28.
- Results publication: PubMed 17095974Fujii T, Watanabe Y, Shiono N, Kawasaki M, Yokomuro H, Ozawa T, Hamada S, Masuhara H, Teramoto T, Hara M, Katayanagi T, Sasaki Y, Koyama N. Assessment of on-pump beating coronary artery bypass surgery performed after introduction of off-pump approach. Ann Thorac Cardiovasc Surg. 2006 Oct;12(5):324-32.
- Results publication: PubMed 24284147Erkut B, Dag O, Kaygin MA, Senocak M, Limandal HK, Arslan U, Kiymaz A, Aydin A, Kahraman N, Calik ES. On-pump beating-heart versus conventional coronary artery bypass grafting for revascularization in patients with severe left ventricular dysfunction: early outcomes. Can J Surg. 2013 Dec;56(6):398-404. doi: 10.1503/cjs.018412.
- Results publication: PubMed 17875971Mazzei V, Nasso G, Salamone G, Castorino F, Tommasini A, Anselmi A. Prospective randomized comparison of coronary bypass grafting with minimal extracorporeal circulation system (MECC) versus off-pump coronary surgery. Circulation. 2007 Oct 16;116(16):1761-7. doi: 10.1161/CIRCULATIONAHA.107.697482. Epub 2007 Sep 17.
- Results publication: PubMed 25535178Al Jaaly E, Chaudhry UA, Harling L, Athanasiou T. Should we consider beating-heart on-pump coronary artery bypass grafting over conventional cardioplegic arrest to improve postoperative outcomes in selected patients? Interact Cardiovasc Thorac Surg. 2015 Apr;20(4):538-45. doi: 10.1093/icvts/ivu425. Epub 2014 Dec 21.
- Results publication: PubMed 19101266Stassano P, Di Tommaso L, Monaco M, Iesu S, Brando G, Buonpane S, Ambrosio G, Di Benedetto G, Pepino P. Myocardial revascularization by left ventricular assisted beating heart is associated with reduced systemic inflammatory response. Ann Thorac Surg. 2009 Jan;87(1):46-52. doi: 10.1016/j.athoracsur.2008.07.098.
- Results publication: PubMed 15937002Gulcan O, Turkoz R, Turkoz A, Caliskan E, Sezgin AT. On-pump/beating-heart myocardial protection for isolated or combined coronary artery bypass grafting in patients with severe left ventricle dysfunction: assessment of myocardial function and clinical outcome. Heart Surg Forum. 2005;8(3):E178-82; discussion E183. doi: 10.1532/HSF98.20041166.
- Results publication: PubMed 18597673Ferrari E, Stalder N, von Segesser LK. On-pump beating heart coronary surgery for high risk patients requiring emergency multiple coronary artery bypass grafting. J Cardiothorac Surg. 2008 Jul 2;3:38. doi: 10.1186/1749-8090-3-38.
- Results publication: PubMed 12611727Folliguet TA, Philippe F, Larrazet F, Dibie A, Czitrom D, Le Bret E, Bachet J, Laborde F. Beating heart revascularization with minimal extracorporeal circulation in patients with a poor ejection fraction. Heart Surg Forum. 2002;6(1):19-23. doi: 10.1532/hsf.992.
- Individual participant dataSharing planned: No
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Coronary Artery Bypass Graft (CABG)
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.
Zhaoyun Cheng, MD study director
Henan Provincial People' Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing left ventricular assist and Biventricular assist in people with Coronary Artery Bypass, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 2021. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Changes of C-reactive protein (CRP) (time frame: up tp 72 hours). 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 NCT02731794, 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 9 Mar 2021.