Heart Failure, CongestiveNCT00121485
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
A study testing Left Ventricular Assist System (LVAS) in people with Heart Failure, Congestive and Ventricular Dysfunction, run by Abbott Medical Devices at 47 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- What is being tested?
- Left Ventricular Assist System (LVAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 47 sitesin 2 countries
- Study dates
- Feb 2005to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The following are general criteria; more specific conditions are included in the study protocol:
- Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
- On optimal medical management and are failing to respond; or
- In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
- Treated with ACE inhibitors or beta-blockers and found to be intolerant.
- Ineligible for cardiac transplant
- VO2max <=14 ml/kg/min
- LVEF <=25%
Who cannot join
- The following are general criteria; more specific conditions are included in the study protocol:
- Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
- Existence of factors that would adversely affect patient survival or function of the LVAS
- Intolerance to anticoagulant or antiplatelet therapies.
- Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome
Trial locations and contacts
47 sites in 2 countries.
47 sites in 2 countries
United States45 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Tufts / New England Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43212
Medical City Hospital Dallas
Dallas, Texas, 75230
University of Colorado Hospital
Denver, Colorado, 80262
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Shands Hospital @ University of Florida
Gainesville, Florida, 32610
Milton Hershey Medical Center
Hershey, Pennsylvania, 17033
Texas Heart Institute
Houston, Texas, 77030
Methodist Hospital
Indianapolis, Indiana, 46206
Bryan LGH Heart Institute
Lincoln, Nebraska, 68516
Jewish Hospital
Louisville, Kentucky, 40202
University of Wisconsin Medical School
Madison, Wisconsin, 53792
Baptist Memorial Hospital
Memphis, Tennessee, 38120
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
University of Minnesota
Minneapolis, Minnesota, 55455
New York Columbia Presbyterian Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23510
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
Hospital of University of PA
Philadelphia, Pennsylvania, 19104
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
LDS Hospital (Intermountain Health Care)
Salt Lake City, Utah, 84143
Sharp Memorial Hospital
San Diego, California, 92123
California Pacific Medical Center
San Francisco, California, 94115
University of Washington
Seattle, Washington, 98195
Sacred Heart Medical Center
Spokane, Washington, 99204
Barnes-Jewish Hospital/Washington University
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Canada2 sites
Hospital Royal Victoria / McGill University Health Centre
Montreal, Quebec, H3A 1A1
Toronto General Hospital
Toronto, Ontario, M5G 2N2
About this study
Official title: The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.
The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
Read the detailed description
The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver.
The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.
- Being tested
- Left Ventricular Assist System (LVAS)
- Keywords
- Heart-assist devices
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Ventricular Assist System (LVAS)Device
Also called Thoratec, HeartMate II, ventricular assist
Implantation of left ventricular assist device for hemodynamic support
| Study group | Role | What they receive |
|---|---|---|
| HeartMate II | Experimental | Implantation of HeartMate II LVAS Receives: Device: Left Ventricular Assist System (LVAS) |
| HeartMate XVE | Active comparator | Implantation of HeartMate XVE LVAS Receives: Device: Left Ventricular Assist System (LVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
Measured: Patients' status at 2 years post-implant
Secondary outcomes (14)
Minnesota Living With Heart Failure Questionnaire(MLWHF)
MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life.
Measured: Baseline, Months 1,3,6,12
Kansas City Cardiomyopathy Questionnaire (KCCQ)
KCCQ is a validated instrument to self assess quality of life including physical function and social function. Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months are presented and indicate improved quality of life.
Measured: Baseline, Months 1, 3, 6, 12
New York Heart Association (NYHA) Classification
NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
Measured: Baseline, Months 1, 6, 12
Six Minute Walk Test (6MWT)
The Six Minute Walk Test(6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
Measured: Baseline, Months 1, 3, 6, 12
Functional Status (Patient Activity Score)
Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High
Measured: Baseline, Months 1, 3, 6, 12
Reoperations
The number of additional surgeries after the initial pump implant. Data is presented as the percentage of patients who required a reoperation for pump replacement or repair, bleeding or other reasons
Measured: Patients were followed until outcome or up to 2 years post-implant, whichever came first
Neurocognitive Assessments, Clock Drawing
Clock drawing is a measure of visual-spatial integrity, visual motor skills and organizational ability. The drawing was administered with the command version with no time restraint. The clock is scored from 1-10, with 10 a better score.
Measured: Baseline (1 month), 6 months
Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
The WMS-LM is a measure of auditory attention and memory. This contextual memory task requires patients to recall a passage read by the examiner. Their memory tasks are avoided during the intervening time so as not to disrupt recall. The WMS-LM test provides a comparision for immediate recall and the WMS-LM Delayed provides a comparison for recall that is delayed 30 minutes. The test is scored in a range from 0-50, where the higher score is considered better
Measured: Baseline (1 month), 6 months
Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)
The WMS-VR is a measure of visual memory. This is a graphic memory task requiring both immediate recall and after a 30 minute delay (WMS-VR Delayed). The scoring range is 0-104 where the higher score is better.
Measured: Baseline (1 month), 6 months
Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)
The WAIS block is a measure of visual spatial and visual motor ability. The patient is given a stimulus configuration to replicate with red and white blocks while being timed, first starting with four blocks and progressing to a nine block configuration. Performance is scored on time upon full completion of the task with a maximum of 68 points. The higher the score, the better.
Measured: Baseline (1 month), 6 months
Neurocognitive Assessments, Boston Naming Test
Fifteen pictures of objects are presented to the patient. The patient is asked to name the object without prompting. A Correct identification represents one point. This test is designed to test language. Scores are from 0-15, higher being better.
Measured: Baseline (1 month), 6 months
Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)
The WAIS Digit is a measure of visual motor speed and abstracting ability. The patient is given the numbers one to nine with an associated symbol. Performance is scored on time with correct amount completed with a maximum of 133 points, where higher is better.
Measured: Baseline (1 month), 6 months
Neurocognitive Assessments, Trail Making A
This is a visual motor task measuring processing speed. The patient is required to draw a line between sequential numbers while being timed to completion. The score is time to completion in seconds and lower score is better.
Measured: Baseline (1 month), 6 months
Neurocognitive Assessments, Trail Making B
This is a visual motor task measuring processing speed and executive functions. The patient is required to draw a line between alternating sequential numbers and letters while being timed to completion. Testing scores are time to completion in seconds with lower score being better.
Measured: Baseline (1 month), 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startFeb 2005
- Primary completionJun 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Pooja Chatterjee, Study director, Thoratec Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121485
- Sponsor's protocol ID
- TC010230-2
- Status last verified
- Jun 2022
- First submitted
- 12 Jul 2005
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, Sun B, Tatooles AJ, Delgado RM 3rd, Long JW, Wozniak TC, Ghumman W, Farrar DJ, Frazier OH; HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17.
PubMed 19920051Petrucci RJ, Rogers JG, Blue L, Gallagher C, Russell SD, Dordunoo D, Jaski BE, Chillcott S, Sun B, Yanssens TL, Tatooles A, Koundakjian L, Farrar DJ, Slaughter MS. Neurocognitive function in destination therapy patients receiving continuous-flow vs pulsatile-flow left ventricular assist device support. J Heart Lung Transplant. 2012 Jan;31(1):27-36. doi: 10.1016/j.healun.2011.10.012.
PubMed 22153550Park SJ, Milano CA, Tatooles AJ, Rogers JG, Adamson RM, Steidley DE, Ewald GA, Sundareswaran KS, Farrar DJ, Slaughter MS; HeartMate II Clinical Investigators. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012 Mar 1;5(2):241-8. doi: 10.1161/CIRCHEARTFAILURE.111.963991. Epub 2012 Jan 26.
PubMed 22282104Brisco MA, Sundareswaran KS, Milano CA, Feldman D, Testani JM, Ewald GA, Slaughter MS, Farrar DJ, Goldberg LR; HeartMate II Clinical Investigators. Incidence, risk, and consequences of atrial arrhythmias in patients with continuous-flow left ventricular assist devices. J Card Surg. 2014 Jul;29(4):572-80. doi: 10.1111/jocs.12336. Epub 2014 Apr 18.
PubMed 24750460
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
- ClinicalTrials.gov ID
- NCT00121485
- Acronym / sponsor ID
- TC010230-2
- Keywords
- Heart-assist devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- Feb 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Posted 29 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.
The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
Detailed description
The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver.
The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartMate II | Experimental | Device: Left Ventricular Assist System (LVAS)Implantation of HeartMate II LVAS |
| HeartMate XVE | Active comparator | Device: Left Ventricular Assist System (LVAS)Implantation of HeartMate XVE LVAS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The following are general criteria; more specific conditions are included in the study protocol:
- Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
- Ineligible for cardiac transplant
- VO2max <=14 ml/kg/min
- LVEF <=25%
Key exclusion criteria (6 listed)
- The following are general criteria; more specific conditions are included in the study protocol:
- Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
- Existence of factors that would adversely affect patient survival or function of the LVAS
- Intolerance to anticoagulant or antiplatelet therapies.
- Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
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 Assist System (LVAS)Also: Thoratec, HeartMate II, ventricular assistImplantation of left ventricular assist device for hemodynamic support | Device | HeartMate II, HeartMate XVE |
Primary outcome
Composite Endpoint
Time frame: Patients' status at 2 years post-implant
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
14 secondary outcomes
Minnesota Living With Heart Failure Questionnaire(MLWHF)
Time frame: Baseline, Months 1,3,6,12
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline, Months 1, 3, 6, 12
New York Heart Association (NYHA) Classification
Time frame: Baseline, Months 1, 6, 12
Six Minute Walk Test (6MWT)
Time frame: Baseline, Months 1, 3, 6, 12
Functional Status (Patient Activity Score)
Time frame: Baseline, Months 1, 3, 6, 12
Reoperations
Time frame: Patients were followed until outcome or up to 2 years post-implant, whichever came first
Neurocognitive Assessments, Clock Drawing
Time frame: Baseline (1 month), 6 months
Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
Time frame: Baseline (1 month), 6 months
Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)
Time frame: Baseline (1 month), 6 months
Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)
Time frame: Baseline (1 month), 6 months
Neurocognitive Assessments, Boston Naming Test
Time frame: Baseline (1 month), 6 months
Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)
Time frame: Baseline (1 month), 6 months
Neurocognitive Assessments, Trail Making A
Time frame: Baseline (1 month), 6 months
Neurocognitive Assessments, Trail Making B
Time frame: Baseline (1 month), 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19920051Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, Sun B, Tatooles AJ, Delgado RM 3rd, Long JW, Wozniak TC, Ghumman W, Farrar DJ, Frazier OH; HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17.
- Results publication: PubMed 22153550Petrucci RJ, Rogers JG, Blue L, Gallagher C, Russell SD, Dordunoo D, Jaski BE, Chillcott S, Sun B, Yanssens TL, Tatooles A, Koundakjian L, Farrar DJ, Slaughter MS. Neurocognitive function in destination therapy patients receiving continuous-flow vs pulsatile-flow left ventricular assist device support. J Heart Lung Transplant. 2012 Jan;31(1):27-36. doi: 10.1016/j.healun.2011.10.012.
- Results publication: PubMed 22282104Park SJ, Milano CA, Tatooles AJ, Rogers JG, Adamson RM, Steidley DE, Ewald GA, Sundareswaran KS, Farrar DJ, Slaughter MS; HeartMate II Clinical Investigators. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012 Mar 1;5(2):241-8. doi: 10.1161/CIRCHEARTFAILURE.111.963991. Epub 2012 Jan 26.
- Derived from this study: PubMed 24750460Brisco MA, Sundareswaran KS, Milano CA, Feldman D, Testani JM, Ewald GA, Slaughter MS, Farrar DJ, Goldberg LR; HeartMate II Clinical Investigators. Incidence, risk, and consequences of atrial arrhythmias in patients with continuous-flow left ventricular assist devices. J Card Surg. 2014 Jul;29(4):572-80. doi: 10.1111/jocs.12336. Epub 2014 Apr 18.
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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.
Pooja Chatterjee study director
Thoratec Corporation
47 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Ventricular Assist System (LVAS) in people with Heart Failure, Congestive and Ventricular Dysfunction, run by Abbott Medical Devices at 47 sites in 2 countries.
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 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Endpoint (time frame: Patients' status at 2 years post-implant). 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 NCT00121485, which also lists 4 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 27 Jun 2022.