Atrial FibrillationaMAZENCT02513797
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
A study testing LARIAT + PVI and Pulmonary Vein Isolation in people with Atrial Fibrillation, run by AtriCure, Inc. at 53 sites in United States.
Trial summary
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- LARIAT + PVI and Pulmonary Vein Isolation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 53 sitesUnited States
- Study dates
- Sep 2015to Mar 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of symptomatic continuous persistent or longstanding persistent non-valvular atrial fibrillation
- Failed at least one Class I or III Antiarrythmic drug (AAD) and therefore, eligible and intended for standard of care catheter ablation;
- Life expectancy ≥ 1 year;
- Willing and able to return to and comply with scheduled follow-up visits and tests; and
- Willing and able to provide written informed consent
Who cannot join
- Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where adhesions are suspected;
- Any prior epicardial ablation or any type of left-sided atrial ablation procedure;
- LA diameter > 6 cm as measured by computerized tomography and confirmed by the imaging core laboratory;
- Documented embolic stroke, transient ischemic attach or suspected neurologic event within 3 months prior to the planned study intervention;
- Currently exhibits New York Heart Association Class IV heart failure symptoms;
- Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
Show all 43Show fewer
- Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
- Documented history of unstable angina within 3 months prior to the planned study intervention;
- Documented history of cardiogenic shock, hemodynamic instability or any medical condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated within 3 months prior to the planned study intervention;
- Documented symptomatic carotid disease, defined as > 70% stenosis or > 50% stenosis with symptoms;
- Diagnosed active local or systemic infection, septicemia or fever of unknown origin at tme of baseline screening;
- Chronic renal insufficiency defined as eGFR < 30 mL/min/1.73m2 within 3 months prior to planned study intervention;
- End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;
- Current documented history of clinically significant liver disease which predisposes the subject to significant bleeding risk (clinically defined by the treating physician);
- Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer;
- Current documented use of long-term treatment with oral corticoid steroids, not including use of inhaled steroids for respiratory diseases;
- Active pericarditis;
- Active endocarditis;
- Any documented history or autoimmune disease associated with pericarditis;
- Evidence of Pectus Excavatum (documented and clinically defined by the treating physician);
- Untreated severe scoliosis (documented and clinically defined by treating physician);
- Documented Left Ventricular Ejection Fraction (LVEF) < 30% within 30 days prior to planned intervention;
- Documented presence of implanted congenital defect closure devices, (e.g., atrial septal defect, patent foramen ovale or ventricular septal defect device);
- Previously attempted occlusion of the left atrial appendage (by any surgical or percutaneous method);
- Inability, or unwillingness or contraindication to undergo TEE or CTA imaging or 24-hour Holter monitoring;
- Body Mass Index (BMI) > 40;
- Evidence of active Graves disease;
- Current untreated hypothyroidism;
- Any contraindication to suture, endovascular device, or other minimally invasive techniques including percutaneous, transseptal, and/or sub-xiphoid access;
- Subject is pregnant or plans / desires to get pregnant within next 12 months;
- Current enrollment in an investigation or study of an investigational device or investigational drug that would interfere with this study and the required follow up;
- Mental impairment or other psychiatric conditions which may not allow patient to understand the nature, significance and scope of the study;
- Any other criteria, medical illness or comorbidity which would make the subject unsuitable to participate in this study as determined by the clinical site Primary Investigator;
- Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging
- Subjects will also be excluded if they meet any of the following:
- Based on screening computed tomography angiography performed within 90 days prior to study intervention as confirmed by the core lab:
- Left atrial appendage morphology: Superior-posterior oriented left atrial appendage (i.e. superior C shape), that has Left atrial appendage distal apex extending posterior to the ostium of the appendage.
- Left atrial appendage positioned behind the pulmonary artery; or
- All other left atrial morphology: Left atrial appendage LARIAT approach width > 50 mm.
- Based on a peri-procedural imaging (transesophageal echocardiography) at time of LARIAT or catheter ablation) and confirmed by institution's designated LARIAT echocardiographer:
- Intracardiac thrombus; or
- Significant mitral valve stenosis (i.e., mitral valve stenosis < 1.5cm2)
- NOTE: It is anticipated that a majority of subjects enrolled in the aMAZE Trial will be elderly US Medicare beneficiaries. Therefore, the results from the aMAZE Trial are expected to be generalizable to the Medicare population.
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Piedmont Athens Regional Cardiology
Athens, Georgia, 30606
Emory University Hospital
Atlanta, Georgia, 30342
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Austin Heart
Austin, Texas, 78756
Johns Hopkins
Baltimore, Maryland, 21287
Maimonides Medical Center
Brooklyn, New York, 11219
Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Trident Medical Center
Charleston, South Carolina, 29406
Medical University of South Carolina
Charleston, South Carolina, 29466
Northwestern University / Bluhm Cardiovascular Institute
Chicago, Illinois, 60611
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
The Ohio Health Research Institute
Columbus, Ohio, 43214
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The Queen's Medical Center
Honolulu, Hawaii, 96813
Cardiovascular Institute of the South Clinical Research Corporation
Houma, Louisiana, 70360
Baylor - St. Luke's Medical Center
Houston, Texas, 77030
Houston Methodist
Houston, Texas, 77030
St. Vincent's HealthCare
Jacksonville, Florida, 32204
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
St. Luke's Hospital
Kansas City, Missouri, 64111
Scripps Clinic
La Jolla, California, 92037
University of California San Diego
La Jolla, California, 92037
DaVita Medical Group
Las Vegas, Nevada, 89169
University of Kentucky
Lexington, Kentucky, 40536
University of Southern California
Los Angeles, California, 90033
UP Health System- Marquette
Marquette, Michigan, 49855
Loyola University Center for Heart and Vascular Medicine
Maywood, Illinois, 60153
Southern Oregon Cardiology
Medford, Oregon, 97504
Morristown Medical Center
Morristown, New Jersey, 07960
Community Hospital
Munster, Indiana, 46321
Vanderbilt University
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
Ochsner Medical Center
New Orleans, Louisiana, 70121
New York University Langone Medical Center
New York, New York, 10016
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Kansas City Cardiac Arrhythmia Research
Overland Park, Kansas, 66215
Arizona Arrhythmia Research Center
Phoenix, Arizona, 85013
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85018
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Baylor Plano Scott & White Research Institute Heart Hospital
Plano, Texas, 75093
Oregon Health & Science University
Portland, Oregon, 97239
The Valley Hospital
Ridgewood, New Jersey, 07450
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94143
Santa Barbara Cottage Hospital
Santa Barbara, California, 93103
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Prairie Education and Research Cooperative
Springfield, Illinois, 62769
Stanford University
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
Christus Trinity Mother Frances Health System
Tyler, Texas, 75701
Iowa Heart Center
West Des Moines, Iowa, 50266
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
About this study
Official title: Left Atrial Appendage Ligation With the LARIAT™ Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.
This study will be conducted in two stages:
- Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2)
- Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (COMPLETED) All subjects from both stages will be included in the primary analysis.
- Conditions
- Atrial Fibrillation
- Being tested
- LARIAT + PVI, Pulmonary Vein Isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARIAT + PVIDevice
Also called Left Atrial Appendage ligation + Pulmonary Vein Isolation
Left Atrial Appendage ligation with the LARIAT System initially performed followed by adjunctive pulmonary vein isolation catheter ablation in staged procedures
Pulmonary Vein IsolationDevice
Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| LARIAT + PVI Treatment Group | Experimental | Percutaneously isolate and ligate the Left Atrial Appendage (LAA) from the left atrium (LA) with the LARIAT System prior to planned pulmonary vein isolation (PVI) catheter ablation Receives: Device: LARIAT + PVI; Device: Pulmonary Vein Isolation |
| PVI Catheter Ablation Group | Active comparator | Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation. Receives: Device: Pulmonary Vein Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation
Measured by 24-hour Holter Monitoring
Measured: 12 months following Pulmonary Vein Isolation catheter ablation procedure
Secondary outcomes (2)
Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode > 30 seconds with or without AAD
Measured by 24-hour Holter Monitoring
Measured: Following the 90 day blanking period through 12 months post-index pulmonary vein isolation
Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee
Measured: 12 months following index pulmonary vein isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion21 Apr 2021
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Wilber, MD, Study chair, Loyola University Department of MedicineDhanunjaya Lakkireddy, MD, Study chair, Kansas City Cardiac Arrhythmia Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513797
- Sponsor's protocol ID
- RS-011
- Acronym
- aMAZE
- Status last verified
- Sep 2021
- First submitted
- 30 Jul 2015
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee RJ, Lakkireddy D, Mittal S, Ellis C, Connor JT, Saville BR, Wilber D. Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): Rationale and design. Am Heart J. 2015 Dec;170(6):1184-94. doi: 10.1016/j.ahj.2015.09.019. Epub 2015 Oct 3.
PubMed 26678640Lakkireddy D, Wilber DJ, Mittal S, Tschopp DR, Ellis CR, Rasekh A, Hounshell T, Hoyt R, Evonich RF, Chandhok S, Berger RD, Horton R, Hoskins M, Calkins H, Yakubov SJ, Khalique OK, Pulerwitz TC, Badhwar N, Dewland T, Weiner S, Valsaiwala S, Katapadi A, Simons P, Walker P, Ndilkintum N, DiBiase L, Natale A, Lee RJ; aMAZE Investigators. Effect of Left Atrial Size and Volume Reduction on Pulmonary Vein Isolation Efficacy in Patients With Persistent and Longstanding Persistent Atrial Fibrillation: Subset Analysis From the aMAZE Trial. Circ Arrhythm Electrophysiol. 2026 Aug;19(8):e014755. doi: 10.1161/CIRCEP.125.014755. Epub 2026 Jul 28.
PubMed 42517227Lakkireddy DR, Wilber DJ, Mittal S, Tschopp D, Ellis CR, Rasekh A, Hounshell T, Evonich R, Chandhok S, Berger RD, Horton R, Hoskins MH, Calkins H, Yakubov SJ, Simons P, Saville BR, Lee RJ; aMAZE Investigators. Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation: The aMAZE Randomized Clinical Trial. JAMA. 2024 Apr 2;331(13):1099-1108. doi: 10.1001/jama.2024.3026.
PubMed 38563835
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Appendage Ligation With the LARIAT™ Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02513797
- Acronym / sponsor ID
- aMAZE / RS-011
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- Mar 2022 (estimated)
- First posted
- 3 Aug 2015 (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.
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.
This study will be conducted in two stages:
- Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2)
- Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (COMPLETED) All subjects from both stages will be included in the primary analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LARIAT + PVI Treatment Group | Experimental | Device: LARIAT + PVI, Device: Pulmonary Vein IsolationPercutaneously isolate and ligate the Left Atrial Appendage (LAA) from the left atrium (LA) with the LARIAT System prior to planned pulmonary vein isolation (PVI) catheter ablation |
| PVI Catheter Ablation Group | Active comparator | Device: Pulmonary Vein IsolationPerform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented diagnosis of symptomatic continuous persistent or longstanding persistent non-valvular atrial fibrillation
- Failed at least one Class I or III Antiarrythmic drug (AAD) and therefore, eligible and intended for standard of care catheter ablation;
- Life expectancy ≥ 1 year;
- Willing and able to return to and comply with scheduled follow-up visits and tests; and
- Willing and able to provide written informed consent
Key exclusion criteria (43 listed)
- Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where adhesions are suspected;
- Any prior epicardial ablation or any type of left-sided atrial ablation procedure;
- LA diameter > 6 cm as measured by computerized tomography and confirmed by the imaging core laboratory;
- Documented embolic stroke, transient ischemic attach or suspected neurologic event within 3 months prior to the planned study intervention;
- Currently exhibits New York Heart Association Class IV heart failure symptoms;
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 |
|---|---|---|
| LARIAT + PVIAlso: Left Atrial Appendage ligation + Pulmonary Vein IsolationLeft Atrial Appendage ligation with the LARIAT System initially performed followed by adjunctive pulmonary vein isolation catheter ablation in staged procedures | Device | LARIAT + PVI Treatment Group |
| Pulmonary Vein IsolationPerform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation. | Device | LARIAT + PVI Treatment Group, PVI Catheter Ablation Group |
Primary outcome
Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation
Time frame: 12 months following Pulmonary Vein Isolation catheter ablation procedure
Measured by 24-hour Holter Monitoring
2 secondary outcomes
Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode > 30 seconds with or without AAD
Time frame: Following the 90 day blanking period through 12 months post-index pulmonary vein isolation
Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee
Time frame: 12 months following index pulmonary vein isolation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 26678640Lee RJ, Lakkireddy D, Mittal S, Ellis C, Connor JT, Saville BR, Wilber D. Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): Rationale and design. Am Heart J. 2015 Dec;170(6):1184-94. doi: 10.1016/j.ahj.2015.09.019. Epub 2015 Oct 3.
- Derived from this study: PubMed 42517227Lakkireddy D, Wilber DJ, Mittal S, Tschopp DR, Ellis CR, Rasekh A, Hounshell T, Hoyt R, Evonich RF, Chandhok S, Berger RD, Horton R, Hoskins M, Calkins H, Yakubov SJ, Khalique OK, Pulerwitz TC, Badhwar N, Dewland T, Weiner S, Valsaiwala S, Katapadi A, Simons P, Walker P, Ndilkintum N, DiBiase L, Natale A, Lee RJ; aMAZE Investigators. Effect of Left Atrial Size and Volume Reduction on Pulmonary Vein Isolation Efficacy in Patients With Persistent and Longstanding Persistent Atrial Fibrillation: Subset Analysis From the aMAZE Trial. Circ Arrhythm Electrophysiol. 2026 Aug;19(8):e014755. doi: 10.1161/CIRCEP.125.014755. Epub 2026 Jul 28.
- Derived from this study: PubMed 38563835Lakkireddy DR, Wilber DJ, Mittal S, Tschopp D, Ellis CR, Rasekh A, Hounshell T, Evonich R, Chandhok S, Berger RD, Horton R, Hoskins MH, Calkins H, Yakubov SJ, Simons P, Saville BR, Lee RJ; aMAZE Investigators. Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation: The aMAZE Randomized Clinical Trial. JAMA. 2024 Apr 2;331(13):1099-1108. doi: 10.1001/jama.2024.3026.
- aMAZE Trial websiteLink provided by the sponsor.
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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.
David J Wilber, MD study chair
Loyola University Department of Medicine
Dhanunjaya Lakkireddy, MD study chair
Kansas City Cardiac Arrhythmia Research
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LARIAT + PVI and Pulmonary Vein Isolation in people with Atrial Fibrillation, run by AtriCure, Inc. at 53 sites 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 5 inclusion and 43 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites 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?
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?
Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation (time frame: 12 months following Pulmonary Vein Isolation catheter ablation procedure). 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 NCT02513797, which also lists 3 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 Sep 2021.