Congenital Heart DiseaseNCT05241418
Atrial Late Gadolinium Enhancement in Patients With Repaired Congenital Heart Disease
An observational study of Congenital Heart Disease and Fibrosis Myocardial, run by Boston Children's Hospital at 1 site in United States.
Trial summary
In this research study the investigators want to learn more about how well the investigators can visualize scar tissue in the heart by MRI. In patients with congenital heart disease who need a procedure in the electrophysiology laboratory, how the MRI findings match the findings in the electrophysiology laboratory is… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Congenital Heart Disease, Fibrosis Myocardial, Fibrosis; Heart
- What is being tested?
- Atrial 3D late gadolinium enhancement
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 30 Jun 2029
- Phase
- Observational
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The hospital at which the investigators are based is a referral center for patients with congenital heart disease. These patients sometimes require a cardiac MRI. Patients >13 years old with congenital heart disease referred for CMR and meeting eligibility criteria will be approached for this study.
Who may be able to join
- Patients >13 years old with congenital heart disease referred for cardiac MRI and receiving gadolinium as part of routine clinical care or for pre-ablation planning will be included.
Who cannot join
- Those with self-reported anxiety or claustrophobia and/or the presence of a permanent pacemaker or implantable cardioverter defibrillator will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02130
About this study
In this research study the investigators want to learn more about how well the investigators can visualize scar tissue in the heart by MRI. In patients with congenital heart disease who need a procedure in the electrophysiology laboratory, how the MRI findings match the findings in the electrophysiology laboratory is not known. This study works to answer these questions. Participants will undergo a cardiac MRI as part of the routine clinical care that was ordered by their doctors and additional imaging by cardiac MRI will be performed.
Read the detailed description
Atrial arrhythmias including intra-atrial reentrant tachycardia (IART) and atrial fibrillation (AF) routinely develop after surgical repair of congenital heart disease (CHD), contributing to heart failure exacerbation, increased hospital resource use, and reduced health-related quality of life. The combination of atriotomy scars, intra-cardiac suture lines, and chronic pressure or volume overload from residual lesions creates the necessary milieu of heterogeneous atrial fibrosis capable of supporting wavefront reentry. While catheter ablation has become a primary tool in the management of IART and AF, long-term ablation outcomes have stagnated over the preceding decade despite advances in mapping and ablative technologies. Left atrial (LA) fibrosis analysis using 3-dimensional (3D) late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMR) has shown utility in the management of adults with structurally normal hearts and atrial fibrillation (AF), having associations with endocardial bipolar voltage amplitude, likelihood of maintenance of sinus rhythm after ablation, and thromboembolic risk. Excellent reproducibility of LA fibrosis quantification has been demonstrated in adults with structurally normal hearts and AF. To date, the use of 3D LGE in CHD has been limited to the ventricles. Prior studies have described altered LA function in adolescent and young adult patients with rTOF. Additionally, right atrial (RA) functional abnormalities have also been described in patients with rTOF. No prior studies have attempted to validate this technology in the atrium of patients with congenital heart disease. Our studies aims to investigate the reproducibility of atrial fibrosis quantification by cardiac MRI and may provide insights to correlations with voltage mapping in the electrophysiology laboratory.
- Being tested
- Atrial 3D late gadolinium enhancement
- Keywords
- Late gadolinium enhancement, 3D late gadolinium enhancement, atrial late gadolinium enhancement, Cardiac MRI, Congenital heart disease
- Medical subject headings
- Heart Defects, Congenital, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial 3D late gadolinium enhancementDiagnostic test
Also called Atrial 3D LGE
We will use cardiac MRI to take a picture of the atria. This picture will be used to identify scar tissue within the atria.
| Study group | Role | What they receive |
|---|---|---|
| Patients with congenital heart disease undergoing a cardiac MRI with Gadolinium | Patients with congenital heart disease who are undergoing a clinically-ordered cardiac MRI and as part of that MRI the contrast agent, Gadolinium, will be administered. Receives: Diagnostic Test: Atrial 3D late gadolinium enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total atrial fibrosis content from 3D-LGE-CMR
Atrial 3D-LGE-CMR images will be post-processed using the Circle ADAS 3D software module (Circle Cardiovascular Inc., Calgary, AB, Canada) and analyzed to identify fibrotic tissue. Results are portrayed as 3D-colored maps and as a calculated percentage of atrial fibrosis relative to total atrial surface area. All CMR images will be analyzed by two observers for the calculation of interrater reliability of the percent of atrial LGE. One observer will perform contours twice for the purposes of intra-observer agreement.
Measured: 1 year
Secondary outcomes (2)
Total atrial fibrosis content from catheter-derived endocardial bipolar voltage map.
In patients who have a cardiac MRI and then an electrophysiology study as part of their clinical care, the 3D-CMR image will be compared to the catheter-generated electro-anatomic voltage mapping obtained in the electrophysiology laboratory.
Measured: 2 years
Sustained atrial arrhythmia, defined as IART/AF lasting >30 seconds detected on ECG, ambulatory monitor, or inpatient telemetry
Following 3D-LGE-CMR acquisition, CMR and clinical data will be entered into a deidentified database to be used for clinical research. After 5 years patients without a prior history of electrophysiology issues will be analyzed prospectively (over a 5 year period) for the development of a sustained atrial arrhythmia using time-to-event analysis.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start23 Mar 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Castellanos, Boston Children's Hospital
- Investigators
- Daniel A Castellanos, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241418
- Sponsor's protocol ID
- P00040666
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouchardy J, Therrien J, Pilote L, Ionescu-Ittu R, Martucci G, Bottega N, Marelli AJ. Atrial arrhythmias in adults with congenital heart disease. Circulation. 2009 Oct 27;120(17):1679-86. doi: 10.1161/CIRCULATIONAHA.109.866319. Epub 2009 Oct 12.
PubMed 19822808Labombarda F, Hamilton R, Shohoudi A, Aboulhosn J, Broberg CS, Chaix MA, Cohen S, Cook S, Dore A, Fernandes SM, Fournier A, Kay J, Macle L, Mondesert B, Mongeon FP, Opotowsky AR, Proietti A, Rivard L, Ting J, Thibault B, Zaidi A, Khairy P; AARCC. Increasing Prevalence of Atrial Fibrillation and Permanent Atrial Arrhythmias in Congenital Heart Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):857-865. doi: 10.1016/j.jacc.2017.06.034.
PubMed 28797355Akoum N, Fernandez G, Wilson B, Mcgann C, Kholmovski E, Marrouche N. Association of atrial fibrosis quantified using LGE-MRI with atrial appendage thrombus and spontaneous contrast on transesophageal echocardiography in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2013 Oct;24(10):1104-9. doi: 10.1111/jce.12199. Epub 2013 Jul 11.
PubMed 23844972Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.
PubMed 24496537Chelu MG, King JB, Kholmovski EG, Ma J, Gal P, Marashly Q, AlJuaid MA, Kaur G, Silver MA, Johnson KA, Suksaranjit P, Wilson BD, Han FT, Elvan A, Marrouche NF. Atrial Fibrosis by Late Gadolinium Enhancement Magnetic Resonance Imaging and Catheter Ablation of Atrial Fibrillation: 5-Year Follow-Up Data. J Am Heart Assoc. 2018 Dec 4;7(23):e006313. doi: 10.1161/JAHA.117.006313.
PubMed 30511895King JB, Azadani PN, Suksaranjit P, Bress AP, Witt DM, Han FT, Chelu MG, Silver MA, Biskupiak J, Wilson BD, Morris AK, Kholmovski EG, Marrouche N. Left Atrial Fibrosis and Risk of Cerebrovascular and Cardiovascular Events in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Sep 12;70(11):1311-1321. doi: 10.1016/j.jacc.2017.07.758.
PubMed 28882227Chubb H, Aziz S, Karim R, Sohns C, Razeghi O, Williams SE, Whitaker J, Harrison J, Chiribiri A, Schaeffter T, Wright M, O'Neill M, Razavi R. Optimization of late gadolinium enhancement cardiovascular magnetic resonance imaging of post-ablation atrial scar: a cross-over study. J Cardiovasc Magn Reson. 2018 May 3;20(1):30. doi: 10.1186/s12968-018-0449-8.
PubMed 29720202Rivas-Gandara N, Dos-Subira L, Francisco-Pascual J, Rodriguez-Garcia J, Pijuan-Domenech A, Benito B, Valente F, Pascual-Gonzalez G, Santos-Ortega A, Miranda B, Perez-Rodon J, Ribera-Sole A, Burcet-Rodriguez G, Roses-Noguer F, Gordon B, Rodriguez-Palomares J, Ferreira-Gonzalez I. Substrate characterization of the right ventricle in repaired tetralogy of Fallot using late enhancement cardiac magnetic resonance. Heart Rhythm. 2021 Nov;18(11):1868-1875. doi: 10.1016/j.hrthm.2021.05.032. Epub 2021 Jun 19.
PubMed 34098087Ghonim S, Ernst S, Keegan J, Giannakidis A, Spadotto V, Voges I, Smith GC, Boutsikou M, Montanaro C, Wong T, Ho SY, McCarthy KP, Shore DF, Dimopoulos K, Uebing A, Swan L, Li W, Pennell DJ, Gatzoulis MA, Babu-Narayan SV. Three-Dimensional Late Gadolinium Enhancement Cardiovascular Magnetic Resonance Predicts Inducibility of Ventricular Tachycardia in Adults With Repaired Tetralogy of Fallot. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008321. doi: 10.1161/CIRCEP.119.008321. Epub 2020 Oct 6.
PubMed 33022183
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Late Gadolinium Enhancement in Patients With Repaired Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05241418
- Acronym / sponsor ID
- P00040666
- Keywords
- Late gadolinium enhancement, 3D late gadolinium enhancement, atrial late gadolinium enhancement, Cardiac MRI, Congenital heart disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 15 Feb 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.
In this research study the investigators want to learn more about how well the investigators can visualize scar tissue in the heart by MRI. In patients with congenital heart disease who need a procedure in the electrophysiology laboratory, how the MRI findings match the findings in the electrophysiology laboratory is not known. This study works to answer these questions. Participants will undergo a cardiac MRI as part of the routine clinical care that was ordered by their doctors and additional imaging by cardiac MRI will be performed.
Detailed description
Atrial arrhythmias including intra-atrial reentrant tachycardia (IART) and atrial fibrillation (AF) routinely develop after surgical repair of congenital heart disease (CHD), contributing to heart failure exacerbation, increased hospital resource use, and reduced health-related quality of life. The combination of atriotomy scars, intra-cardiac suture lines, and chronic pressure or volume overload from residual lesions creates the necessary milieu of heterogeneous atrial fibrosis capable of supporting wavefront reentry. While catheter ablation has become a primary tool in the management of IART and AF, long-term ablation outcomes have stagnated over the preceding decade despite advances in mapping and ablative technologies. Left atrial (LA) fibrosis analysis using 3-dimensional (3D) late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMR) has shown utility in the management of adults with structurally normal hearts and atrial fibrillation (AF), having associations with endocardial bipolar voltage amplitude, likelihood of maintenance of sinus rhythm after ablation, and thromboembolic risk. Excellent reproducibility of LA fibrosis quantification has been demonstrated in adults with structurally normal hearts and AF. To date, the use of 3D LGE in CHD has been limited to the ventricles. Prior studies have described altered LA function in adolescent and young adult patients with rTOF. Additionally, right atrial (RA) functional abnormalities have also been described in patients with rTOF. No prior studies have attempted to validate this technology in the atrium of patients with congenital heart disease. Our studies aims to investigate the reproducibility of atrial fibrosis quantification by cardiac MRI and may provide insights to correlations with voltage mapping in the electrophysiology laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with congenital heart disease undergoing a cardiac MRI with Gadolinium | – | Diagnostic Test: Atrial 3D late gadolinium enhancementPatients with congenital heart disease who are undergoing a clinically-ordered cardiac MRI and as part of that MRI the contrast agent, Gadolinium, will be administered. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The hospital at which the investigators are based is a referral center for patients with congenital heart disease. These patients sometimes require a cardiac MRI. Patients >13 years old with congenital heart disease referred for CMR and meeting eligibility criteria will be approached for this study.
Key inclusion criteria (1 listed)
- Patients >13 years old with congenital heart disease referred for cardiac MRI and receiving gadolinium as part of routine clinical care or for pre-ablation planning will be included.
Key exclusion criteria (1 listed)
- Those with self-reported anxiety or claustrophobia and/or the presence of a permanent pacemaker or implantable cardioverter defibrillator will be excluded.
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 3D late gadolinium enhancementAlso: Atrial 3D LGEWe will use cardiac MRI to take a picture of the atria. This picture will be used to identify scar tissue within the atria. | Diagnostic test | Patients with congenital heart disease undergoing a cardiac MRI with Gadolinium |
Primary outcome
Total atrial fibrosis content from 3D-LGE-CMR
Time frame: 1 year
Atrial 3D-LGE-CMR images will be post-processed using the Circle ADAS 3D software module (Circle Cardiovascular Inc., Calgary, AB, Canada) and analyzed to identify fibrotic tissue. Results are portrayed as 3D-colored maps and as a calculated percentage of atrial fibrosis relative to total atrial surface area. All CMR images will be analyzed by two observers for the calculation of interrater reliability of the percent of atrial LGE. One observer will perform contours twice for the purposes of intra-observer agreement.
2 secondary outcomes
Total atrial fibrosis content from catheter-derived endocardial bipolar voltage map.
Time frame: 2 years
Sustained atrial arrhythmia, defined as IART/AF lasting >30 seconds detected on ECG, ambulatory monitor, or inpatient telemetry
Time frame: 5 years
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 6 Oct 2026.
- Background: PubMed 19822808Bouchardy J, Therrien J, Pilote L, Ionescu-Ittu R, Martucci G, Bottega N, Marelli AJ. Atrial arrhythmias in adults with congenital heart disease. Circulation. 2009 Oct 27;120(17):1679-86. doi: 10.1161/CIRCULATIONAHA.109.866319. Epub 2009 Oct 12.
- Background: PubMed 28797355Labombarda F, Hamilton R, Shohoudi A, Aboulhosn J, Broberg CS, Chaix MA, Cohen S, Cook S, Dore A, Fernandes SM, Fournier A, Kay J, Macle L, Mondesert B, Mongeon FP, Opotowsky AR, Proietti A, Rivard L, Ting J, Thibault B, Zaidi A, Khairy P; AARCC. Increasing Prevalence of Atrial Fibrillation and Permanent Atrial Arrhythmias in Congenital Heart Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):857-865. doi: 10.1016/j.jacc.2017.06.034.
- Background: PubMed 23844972Akoum N, Fernandez G, Wilson B, Mcgann C, Kholmovski E, Marrouche N. Association of atrial fibrosis quantified using LGE-MRI with atrial appendage thrombus and spontaneous contrast on transesophageal echocardiography in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2013 Oct;24(10):1104-9. doi: 10.1111/jce.12199. Epub 2013 Jul 11.
- Background: PubMed 24496537Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.
- Background: PubMed 30511895Chelu MG, King JB, Kholmovski EG, Ma J, Gal P, Marashly Q, AlJuaid MA, Kaur G, Silver MA, Johnson KA, Suksaranjit P, Wilson BD, Han FT, Elvan A, Marrouche NF. Atrial Fibrosis by Late Gadolinium Enhancement Magnetic Resonance Imaging and Catheter Ablation of Atrial Fibrillation: 5-Year Follow-Up Data. J Am Heart Assoc. 2018 Dec 4;7(23):e006313. doi: 10.1161/JAHA.117.006313.
- Background: PubMed 28882227King JB, Azadani PN, Suksaranjit P, Bress AP, Witt DM, Han FT, Chelu MG, Silver MA, Biskupiak J, Wilson BD, Morris AK, Kholmovski EG, Marrouche N. Left Atrial Fibrosis and Risk of Cerebrovascular and Cardiovascular Events in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Sep 12;70(11):1311-1321. doi: 10.1016/j.jacc.2017.07.758.
- Background: PubMed 29720202Chubb H, Aziz S, Karim R, Sohns C, Razeghi O, Williams SE, Whitaker J, Harrison J, Chiribiri A, Schaeffter T, Wright M, O'Neill M, Razavi R. Optimization of late gadolinium enhancement cardiovascular magnetic resonance imaging of post-ablation atrial scar: a cross-over study. J Cardiovasc Magn Reson. 2018 May 3;20(1):30. doi: 10.1186/s12968-018-0449-8.
- Background: PubMed 34098087Rivas-Gandara N, Dos-Subira L, Francisco-Pascual J, Rodriguez-Garcia J, Pijuan-Domenech A, Benito B, Valente F, Pascual-Gonzalez G, Santos-Ortega A, Miranda B, Perez-Rodon J, Ribera-Sole A, Burcet-Rodriguez G, Roses-Noguer F, Gordon B, Rodriguez-Palomares J, Ferreira-Gonzalez I. Substrate characterization of the right ventricle in repaired tetralogy of Fallot using late enhancement cardiac magnetic resonance. Heart Rhythm. 2021 Nov;18(11):1868-1875. doi: 10.1016/j.hrthm.2021.05.032. Epub 2021 Jun 19.
- Background: PubMed 33022183Ghonim S, Ernst S, Keegan J, Giannakidis A, Spadotto V, Voges I, Smith GC, Boutsikou M, Montanaro C, Wong T, Ho SY, McCarthy KP, Shore DF, Dimopoulos K, Uebing A, Swan L, Li W, Pennell DJ, Gatzoulis MA, Babu-Narayan SV. Three-Dimensional Late Gadolinium Enhancement Cardiovascular Magnetic Resonance Predicts Inducibility of Ventricular Tachycardia in Adults With Repaired Tetralogy of Fallot. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008321. doi: 10.1161/CIRCEP.119.008321. Epub 2020 Oct 6.
- 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. This study is not recruiting at the moment.
Daniel A Castellanos, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Fibrosis Myocardial, run by Boston Children's Hospital at 1 site in United States.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. 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 United States. 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?
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?
Total atrial fibrosis content from 3D-LGE-CMR (time frame: 1 year). 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 NCT05241418, which also lists 9 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 6 Oct 2026.