Coronary Artery DiseaseNCT01171625
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
A study testing Implantation of CEP Magna Ease Model 3300TFX in people with Coronary Artery Disease and Aortic Valve Disorder, run by Edwards Lifesciences at 13 sites in 6 countries.
Trial summary
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Aortic Valve Disorder, Heart Failure
- What is being tested?
- Implantation of CEP Magna Ease Model 3300TFX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Oct 2007to Sep 2018
- 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 patient requires, as indicated in the preoperative evaluation, a replacement aortic valve.
- The patient is an average or better operative risk.
- The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years.
- The patient is 18 years or older.
- The patient has signed and dated the subject informed consent form prior to surgery.
Who cannot join
- The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
- The patient presents with active endocarditis within the last 3 months.
- The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism).
- The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome).
- The patient is pregnant or lactating.
- The patient is an intravenous drug abuser.
Show all 12Show fewer
- The patient is currently a prison inmate.
- The patient is currently participating in a study of an investigational drug or device.
- The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve.
- The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device.
- The patient was previously enrolled in the study.
- The patient had a prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ.
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
United States5 sites
Cooper University Hospital
Camden, New Jersey, 08103
Morristown Memorial Hospital
Morristown, New Jersey, 09762
Providence Heart & Vascular Institute
Portland, Oregon, 97225
Mercy General Hospital
Sacramento, California, 95819
St. Marks Hospital
Salt Lake City, Utah, 84124
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Paul's Hospital
Vancouver, V6Z 1Y6
Germany2 sites
Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie
Hanover, D-30625
Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum
Munich, Lazarettstr, 36
United Kingdom2 sites
Blackpool Victoria Hospital
Blackpool, Lancashire, FY8 8NR
Papworth Hospital NHS foundation Trust
Papworth Everard, Cambridge, CV23 3RE
About this study
Official title: Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
Read the detailed description
This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant at discharge, 6 months, one year, and annually for a minimum of 8 years.
- Conditions
- Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis, Aortic Valve Insufficiency
- Being tested
- Implantation of CEP Magna Ease Model 3300TFX
- Keywords
- PERIMOUNT, Aortic valve replacement/regurgitation
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Disease, Heart Failure, Aortic Valve Stenosis, Aortic Valve Insufficiency, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of CEP Magna Ease Model 3300TFXDevice
Also called CEP Magna Ease MOdel 3300TFX
Heart Valve Surgery
| Study group | Role | What they receive |
|---|---|---|
| CEP Aortic Bioprothesis, model 3300TFX | Other | Not described Receives: Device: Implantation of CEP Magna Ease Model 3300TFX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's Percentage of Long Term Safety Performance
Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance.
Expressed as the Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Measured: 31 days through 8 years post-implant
Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Measured: 8 years post-implant
Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Measured: 8 Years post-implant
Secondary outcomes (20)
Percent of Early Adverse Events
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Measured: Events occurring within 30 days of procedure
Percentage of Late Adverse Events
Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Measured: Events occurring >= 31 days and up through 8 years post-implant
Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Measured: 1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant
Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant
Peak systolic gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. The data summary will be stratified by valve size.
Measured: 8 years post-implant
Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.
Mean systolic gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Mean gradient values depend on the size and type of valve. The data summary will be stratified by valve size.
Measured: 8 years post-implant
Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant.
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. The data summary will be stratified by valve size.
Measured: 8 years post-implant
Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant.
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. The data summary will be stratified by valve size.
Measured: 8 years post-implant
Subject's Average Performance Index Measurements at 8 Years Post-implant.
Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. The data summary will be stratified by valve size.
Measured: 8 years post-implant
Subject's Average Cardiac Output Measurements at 8 Years Post-implant.
The amount of blood the heart pumps through the circulatory system in a minute. The data summary will be stratified by valve size.
Measured: 8 years post-implant
Subject's Average Cardiac Index Measurements at 8 Years Post-implant.
Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. The data summary will be stratified by valve size.
Measured: 8 years post-implant
Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant.
Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Measured: 8 years post-implant
Subject's Average White Blood Cell Count Measurement Over Time.
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Measured: 6 months and annually for 8 years post-implant
Subject's Average Red Blood Cells Count Over Time.
Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.
Measured: 6 months and annually for 8 years post-implant
Subject's Average Hematocrit Percentage Over Time.
Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.
Measured: 6 months and annually for 8 years post-implant
Subject's Average Hemoglobin Count Over Time.
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Measured: 6 months and annually for 8 years post-implant
Subject's Average Platelet Count Over Time.
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Measured: 6 months and annually for 8 years post-implant
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time.
Laboratory Analysis of Serum Lactate Dehydrogenase on blood drawn from subjects; The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.
Measured: 6 months and annually for 8 years post-implant
Subject's Average Haptoglobin Measurement Over Time.
Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.
Measured: 6 months and annually for 8 years post-implant
Subject's Average Reticulocytes Percentage Over Time.
Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.
Measured: 6 months and annually for 8 years post-implant
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant.
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from a minimum of 0 and a maximum of 100 where zero is the 'worst state imaginable' and 100 is the 'best state imaginable'.
Measured: Baseline and 6 Months Post-Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startOct 2007
- Primary completionSep 2018
- Study completionSep 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171625
- Sponsor's protocol ID
- 2007-08
- Status last verified
- Apr 2020
- First submitted
- 26 Jul 2010
- Last updated
- 17 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.
PubMed 29912142
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
- ClinicalTrials.gov ID
- NCT01171625
- Acronym / sponsor ID
- 2007-08
- Conditions
- Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis, Aortic Valve Insufficiency
- Keywords
- PERIMOUNT, Aortic valve replacement/regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2007 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Posted 17 Apr 2020
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 the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
Detailed description
This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant at discharge, 6 months, one year, and annually for a minimum of 8 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEP Aortic Bioprothesis, model 3300TFX | Other | Device: Implantation of CEP Magna Ease Model 3300TFX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve.
- The patient is an average or better operative risk.
- The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years.
- The patient is 18 years or older.
- The patient has signed and dated the subject informed consent form prior to surgery.
Key exclusion criteria (12 listed)
- The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
- The patient presents with active endocarditis within the last 3 months.
- The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism).
- The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome).
- The patient is pregnant or lactating.
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 |
|---|---|---|
| Implantation of CEP Magna Ease Model 3300TFXAlso: CEP Magna Ease MOdel 3300TFXHeart Valve Surgery | Device | CEP Aortic Bioprothesis, model 3300TFX |
Primary outcome
Subject's Percentage of Long Term Safety Performance
Time frame: 31 days through 8 years post-implant
Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance. Expressed as the Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant
Time frame: 8 years post-implant
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline
Time frame: 8 Years post-implant
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
20 secondary outcomes
Percent of Early Adverse Events
Time frame: Events occurring within 30 days of procedure
Percentage of Late Adverse Events
Time frame: Events occurring >= 31 days and up through 8 years post-implant
Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
Time frame: 1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant
Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant
Time frame: 8 years post-implant
Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.
Time frame: 8 years post-implant
Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant.
Time frame: 8 years post-implant
Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant.
Time frame: 8 years post-implant
Subject's Average Performance Index Measurements at 8 Years Post-implant.
Time frame: 8 years post-implant
Subject's Average Cardiac Output Measurements at 8 Years Post-implant.
Time frame: 8 years post-implant
Subject's Average Cardiac Index Measurements at 8 Years Post-implant.
Time frame: 8 years post-implant
Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant.
Time frame: 8 years post-implant
Subject's Average White Blood Cell Count Measurement Over Time.
Time frame: 6 months and annually for 8 years post-implant
Subject's Average Red Blood Cells Count Over Time.
Time frame: 6 months and annually for 8 years post-implant
Subject's Average Hematocrit Percentage Over Time.
Time frame: 6 months and annually for 8 years post-implant
Subject's Average Hemoglobin Count Over Time.
Time frame: 6 months and annually for 8 years post-implant
Subject's Average Platelet Count Over Time.
Time frame: 6 months and annually for 8 years post-implant
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time.
Time frame: 6 months and annually for 8 years post-implant
Subject's Average Haptoglobin Measurement Over Time.
Time frame: 6 months and annually for 8 years post-implant
Subject's Average Reticulocytes Percentage Over Time.
Time frame: 6 months and annually for 8 years post-implant
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant.
Time frame: Baseline and 6 Months Post-Implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29912142Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.
- New York Heart Association ClassificationLink 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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of CEP Magna Ease Model 3300TFX in people with Coronary Artery Disease and Aortic Valve Disorder, run by Edwards Lifesciences at 13 sites in 6 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 5 inclusion and 12 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 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada, Germany, United Kingdom, Austria and 1 more country. 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 17 Apr 2020). 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?
Subject's Percentage of Long Term Safety Performance (time frame: 31 days through 8 years post-implant). The study lists 3 primary outcomes in all. 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 NCT01171625, which also lists 1 linked publication.
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 17 Apr 2020.