Aortic Valve StenosisNCT04703699
Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.
An observational study of Aortic Valve Stenosis, run by Meril Life Sciences Pvt. Ltd. at 8 sites in 7 countries.
Trial summary
A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Myval Transcatheter Heart Valve Series
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 7 Aug 2020to 30 Nov 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who have been treated with Myval™ THV series will be selected for the study.
Who may be able to join
- All patients of this study must have received Myval™ THV series for treatment of native severe aortic stenosis and completed a minimum of 30-day follow-up.
Who cannot join
- No
Trial locations and contacts
8 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 7 countries
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35010
Dr. Pedro Martin Lorenzo, +34 616 129540 / 928 284105, pemarlor@hotmail.com
- Recruiting
Hospital Cliinico Univertistario de Valladolid
Valladolid, 47003
Dr. Ignacio A Santos, Medicine & Surgery, +34657923040, ijamat@gmail.com
Jose R Delgado Arana, Medicine
Estonia1 site, 1 recruiting
- Recruiting
North Estonia Medical center
Tallinn
Dr. Peep Laanmets, peep.laanmets@regionaalhaigla.ee
Italy1 site, 1 recruiting
- Recruiting
Clinical Institute Saint Ambrogio
Milan, 20149
Dr. Alfonso Ielasi, MD, +39 338 8433189, alielasi@hotmail.com
Netherlands1 site, 1 recruiting
- Recruiting
Amphia Ziekenhui
Breda, North Brabant, 4818
Dr. A. J. J. IJsselmuiden, MD, Ph.D, +31(0)655814502, siisselmuiden@amphia.nl
Simsek Cihan, Ph.D
Poland1 site, 1 recruiting
- Recruiting
University of Gdansk
Gdansk, Bażyńskiego, 80-309
Prof. Dariusz Jagielak, MD, PhD, +48509487577, darjag@gumed.edu.pl
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana
Prof. Matjaz Bunc, matjaz.bunc@kclj.si
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University School of Medicine
Kocaeli
Prof. Teoman Kilic, kilicteoman@yahoo.com
About this study
Official title: A Retrospective, Multinational, Multicentre, Observational Study in Patients Presenting With Native Severe Aortic Valve Stenosis and Treated With Myval™ Transcatheter Heart Valve Series in Real-world Setting.
A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
Read the detailed description
Myval Global Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
This study shall retrospectively collect the data of minimal 200 consecutive patients treated with Myval™ THV Series approximately 15 participating sites Globally.
Primary Endpoint:
Primary Combined Safety and Effectiveness Endpoint: [Time frame: 30 days]
It is the composite of following:
- All-cause mortality
- All stroke
- Bleeding (type 3 and 4)
- Acute kidney injury (stage 2 ,3 \& 4)
- Major vascular complications
- Moderate or severe prosthetic valve regurgitation
- Conduction system disturbances resulting in a new permanent pacemaker implantation.
Secondary endpoints:
- All-cause mortality (VARC-3 defined criteria) [Time Frame: Through 30 days]
- All stroke (VARC-3 defined criteria) [Time Frame: Through 30 days]
- Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4 [Time Frame: Through 30 days]
- Bleeding type 3 and 4 (VARC-3 criteria) [Time Frame: Through 30 days]
- Moderate or severe prosthetic valve regurgitation [Time Frame: Through 30 days]
- New permanent pacemaker implantation [Time Frame: Through 30 days] New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block.
- Conduction disturbances and arrhythmias according to VARC-3 [Time Frame: Through 30 days]
- Device success (VARC-3 criteria) [Time Frame: Pre-discharge]
- Early safety at 30 days (VARC-3 criteria) [Time Frame: After 30 days of index procedure]
- Clinical efficacy after 30 days (VARC-2 criteria) [Time Frame: After 30 days of index procedure]
- Time-related valve safety (VARC-2 criteria) [Time Frame: Through 30 days]
- Vascular and access related complications (VARC-3 criteria) [Time Frame: Pre-discharge, Through 30 days]
- Major vascular complications (VARC-3 criteria) [Time Frame: Pre-discharge, Through 30 days]
- Functional improvement from baseline as measured per
- NYHA functional classification [Time frame: Baseline, 30 days]
- Echocardiographic End Points
- Effective orifice area (EOA)
- Index effective orifice area (iEOA)
- Mean aortic valve gradient
- Peak aortic valve gradient
- Peak aortic velocity
- Transvalvular, paravalvular and total aortic regurgitation
- Left ventricular ejection fraction (LVEF)
- Valve calcification
- Cardiac output and cardiac index [Time frame: Through 30 days]
- Patient-prosthesis Mismatch: [Time Frame: Post-procedure, predishcarge, Through 30 days] Severity patient-prosthesis-mismatch will be based on following
- For subjects with BMI < 30 kg/m2, index effective orifice area (EOAi) 0.85 - 0.66 cm2 /m2 for moderate and ≤0.65 cm2 /m2 for severe
- For subjects with BMI ≥30 kg/m2, index effective orifice area (EOAi) 0.70 - 0.56 cm2 /m2 for moderate and ≤0.55 cm2 /m2 for severe BMI = weight(kg)/(height (m)) 2
- Length of index hospital stay. [Time frame: At discharge]
- Number of days from hospital admission to discharge.
- Re-hospitalization (VARC-3 defined criteria) [Time Frame: Through 30 days]
- New onset of atrial fibrillation or atrial flutter [Time Frame: Post-procedure, Pre-discharge and 30 days]
- Endocarditis [Time Frame: Through 30 days]
- Major bleeding event [Time Frame: Through 30 days]
- Other Endpoints:
- Myocardial rupture [Time Frame: During procedure]
- Paravalvular leak [Time Frame:Through 30 days]
- Degree of over- or under-expansion of Myval [Time Frame: During procedure]
- Accuracy of deployment in relation to the annular plane [Time Frame: During procedure]
- Pacemaker deployment (and the symptoms resulting in it) [Time Frame: Through 30 days]
- Interference with the mitral valve; and [Time Frame: During procedure]
- Interference with the LVOT [Time Frame: During procedure]
- If the endpoint data is available through 1 year, it will also be collected and analyzed.
Clinical efficacy data will be collected only for patients with availability of data after 30 days follow-up.
Long term clinical follow up by telephonic interview will be conducted for all patients who have completed 30 days safety follow-up, at 1 year, 3 year and 5 years.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Myval Transcatheter Heart Valve Series
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myval Transcatheter Heart Valve SeriesDevice
Also called Myval THV
Myval™ THV is a newer-generation balloon-expandable THV characterized by a nickel-cobalt alloy frame composed of a single element - hexagon arranged in a hybrid honeycomb fashion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3)
It is the composite of following
- All-cause mortality
- All stroke (disabling and non-disabling)
- Life-threatening or disabling bleeding
- Acute kidney injury (stage 2 or 3)
- Major vascular complications
- Moderate or severe prosthetic valve regurgitation
- Conduction system disturbances resulting in a new permanent pacemaker implantation
Measured: 30 day
Secondary outcomes (28)
All-cause mortality
Number of mortality as per VARC - 3 Criteria
Measured: 30 day
All stroke
Measured: Through 30 days
Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4
Number of participants of AKI as per AKIN Network
Measured: Through 30 days
Bleeding type 3 and 4
Number of participants for bleeding as per VARC-3 criteria
Measured: Through 30 days
Moderate or severe prosthetic valve regurgitation
Measured: Through 30 days
New permanent pacemaker implantation
New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block
Measured: Through 30 days
Conduction disturbances and arrhythmias
Number of participants for Conduction disturbances and arrhythmias as per VARC-3 Criteria
Measured: Through 30 days
Device Success
Number of participants for Device success as per VARC-3 Criteria
Measured: During hospital stay or maximum of 7 days after index procedure, whichever is earlier.
Early safety at 30 days
Number of participants for Early safety as per VARC-3 Criteria
Measured: After 30 days of index procedure
Clinical efficacy after 30 days
Number of participants for Clinical efficacy as per VARC-2 Criteria
Measured: After 30 days of index procedure
Time related valve safety
Number of participants for Time related valve safety as per VARC-2 Criteria
Measured: Through 30 days
Vascular and access related complications
Number of participants for Vascular and access related complications as per VARC-3 Criteria
Measured: Pre-discharge, Through 30 days
Major vascular complications
Number of participants for Major vascular complications as per VARC-3 Criteria
Measured: Pre-discharge, Through 30 days
Functional improvement from baseline as measured
Number of participants for Functional improvement as per NYHA functional classification
Measured: Baseline, 30 days
Echocardiographic End Points
- Effective orifice area (EOA)
- Index effective orifice area (iEOA)
- Mean aortic valve gradient
- Peak aortic valve gradient
- Peak aortic velocity
- Transvalvular, paravalvular and total aortic regurgitation
- Left ventricular ejection fraction (LVEF)
- Valve calcification
- Cardiac output and cardiac index
Measured: Through 30 days]
Patient-prosthesis Mismatch
Severity patient-prosthesis-mismatch will be based on following For subjects with BMI < 30 kg/m2, index effective orifice area (EOAi) 0.85 - 0.66 cm2/m2 for moderate and ≤0.65 cm2/m2 for severe For subjects with BMI ≥30 kg/m2, index effective orifice area (EOAi) 0.70 - 0.56 cm2 /m2 for moderate and ≤0.55 cm2/m2 for severe BMI = weight(kg)/(height (m)) 2
Measured: Through 30 days
Length of index hospital stay
Number of days from hospital admission to discharge
Measured: At discharge
Re-hospitalization
Number of participants as per VARC-3 defined criteria
Measured: Through 30 days
New onset of atrial fibrillation or atrial flutter
VARC-3 criteria
Measured: Post-procedure, Pre-discharge and 30 days
Endocarditis
Number of participants for Endocarditis as per VARC-3 criteria
Measured: Through 30 days
Major bleeding event
Number of participants for Major bleeding event as per VARC-3 criteria
Measured: Through 30 days
Myocardial rupture
Number of participants for Myocardial rupture
Measured: During procedure
Paravalvular Leak
Number of participants for Paravalvular Leak
Measured: Through 30 days
Degree of over - or Under-expansion of Myval
Number of participants for Degree of over - or Under-expansion of Myval
Measured: During Procedure
Accuracy of deployment in relation to the annular plane
Number of participants for Accuracy of deployment in relation to the annular plane
Measured: During procedure
Pacemaker deployment (and the symptoms resulting in it)
Number of participants for Pacemaker deployment (and the symptoms resulting in it)
Measured: Through 30 days
Interference with the mitral valve
Number of participants for Interference with the mitral valve
Measured: During procedure
Interference with the LVOT
Number of participants for Interference with the LVOT
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start7 Aug 2020
- Primary completion30 May 2024 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashok Thakkar, Ph.D., Study chair, Head - Clinical Research and Medical Writing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703699
- Sponsor's protocol ID
- MLS/MYV-3/Global study
- Status last verified
- Feb 2024
- First submitted
- 22 Dec 2020
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multinational, Multicentre, Observational Study in Patients Presenting With Native Severe Aortic Valve Stenosis and Treated With Myval™ Transcatheter Heart Valve Series in Real-world Setting.
- ClinicalTrials.gov ID
- NCT04703699
- Acronym / sponsor ID
- MLS/MYV-3/Global study
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 11 Jan 2021 (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.
A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
Detailed description
Myval Global Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
This study shall retrospectively collect the data of minimal 200 consecutive patients treated with Myval™ THV Series approximately 15 participating sites Globally.
Primary Endpoint:
Primary Combined Safety and Effectiveness Endpoint: [Time frame: 30 days]
It is the composite of following:
- All-cause mortality
- All stroke
- Bleeding (type 3 and 4)
- Acute kidney injury (stage 2 ,3 \& 4)
- Major vascular complications
- Moderate or severe prosthetic valve regurgitation
- Conduction system disturbances resulting in a new permanent pacemaker implantation.
Secondary endpoints:
- All-cause mortality (VARC-3 defined criteria) [Time Frame: Through 30 days]
- All stroke (VARC-3 defined criteria) [Time Frame: Through 30 days]
- Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4 [Time Frame: Through 30 days]
- Bleeding type 3 and 4 (VARC-3 criteria) [Time Frame: Through 30 days]
- Moderate or severe prosthetic valve regurgitation [Time Frame: Through 30 days]
- New permanent pacemaker implantation [Time Frame: Through 30 days] New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block.
- Conduction disturbances and arrhythmias according to VARC-3 [Time Frame: Through 30 days]
- Device success (VARC-3 criteria) [Time Frame: Pre-discharge]
- Early safety at 30 days (VARC-3 criteria) [Time Frame: After 30 days of index procedure]
- Clinical efficacy after 30 days (VARC-2 criteria) [Time Frame: After 30 days of index procedure]
- Time-related valve safety (VARC-2 criteria) [Time Frame: Through 30 days]
- Vascular and access related complications (VARC-3 criteria) [Time Frame: Pre-discharge, Through 30 days]
- Major vascular complications (VARC-3 criteria) [Time Frame: Pre-discharge, Through 30 days]
- Functional improvement from baseline as measured per
- NYHA functional classification [Time frame: Baseline, 30 days]
- Echocardiographic End Points
- Effective orifice area (EOA)
- Index effective orifice area (iEOA)
- Mean aortic valve gradient
- Peak aortic valve gradient
- Peak aortic velocity
- Transvalvular, paravalvular and total aortic regurgitation
- Left ventricular ejection fraction (LVEF)
- Valve calcification
- Cardiac output and cardiac index [Time frame: Through 30 days]
- Patient-prosthesis Mismatch: [Time Frame: Post-procedure, predishcarge, Through 30 days] Severity patient-prosthesis-mismatch will be based on following
- For subjects with BMI < 30 kg/m2, index effective orifice area (EOAi) 0.85 - 0.66 cm2 /m2 for moderate and ≤0.65 cm2 /m2 for severe
- For subjects with BMI ≥30 kg/m2, index effective orifice area (EOAi) 0.70 - 0.56 cm2 /m2 for moderate and ≤0.55 cm2 /m2 for severe BMI = weight(kg)/(height (m)) 2
- Length of index hospital stay. [Time frame: At discharge]
- Number of days from hospital admission to discharge.
- Re-hospitalization (VARC-3 defined criteria) [Time Frame: Through 30 days]
- New onset of atrial fibrillation or atrial flutter [Time Frame: Post-procedure, Pre-discharge and 30 days]
- Endocarditis [Time Frame: Through 30 days]
- Major bleeding event [Time Frame: Through 30 days]
- Other Endpoints:
- Myocardial rupture [Time Frame: During procedure]
- Paravalvular leak [Time Frame:Through 30 days]
- Degree of over- or under-expansion of Myval [Time Frame: During procedure]
- Accuracy of deployment in relation to the annular plane [Time Frame: During procedure]
- Pacemaker deployment (and the symptoms resulting in it) [Time Frame: Through 30 days]
- Interference with the mitral valve; and [Time Frame: During procedure]
- Interference with the LVOT [Time Frame: During procedure]
- If the endpoint data is available through 1 year, it will also be collected and analyzed.
Clinical efficacy data will be collected only for patients with availability of data after 30 days follow-up.
Long term clinical follow up by telephonic interview will be conducted for all patients who have completed 30 days safety follow-up, at 1 year, 3 year and 5 years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have been treated with Myval™ THV series will be selected for the study.
Key inclusion criteria (1 listed)
- All patients of this study must have received Myval™ THV series for treatment of native severe aortic stenosis and completed a minimum of 30-day follow-up.
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Myval Transcatheter Heart Valve SeriesAlso: Myval THVMyval™ THV is a newer-generation balloon-expandable THV characterized by a nickel-cobalt alloy frame composed of a single element - hexagon arranged in a hybrid honeycomb fashion. | Device | – |
Primary outcome
Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3)
Time frame: 30 day
It is the composite of following * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening or disabling bleeding * Acute kidney injury (stage 2 or 3) * Major vascular complications * Moderate or severe prosthetic valve regurgitation * Conduction system disturbances resulting in a new permanent pacemaker implantation
28 secondary outcomes
All-cause mortality
Time frame: 30 day
All stroke
Time frame: Through 30 days
Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4
Time frame: Through 30 days
Bleeding type 3 and 4
Time frame: Through 30 days
Moderate or severe prosthetic valve regurgitation
Time frame: Through 30 days
New permanent pacemaker implantation
Time frame: Through 30 days
Conduction disturbances and arrhythmias
Time frame: Through 30 days
Device Success
Time frame: During hospital stay or maximum of 7 days after index procedure, whichever is earlier.
Early safety at 30 days
Time frame: After 30 days of index procedure
Clinical efficacy after 30 days
Time frame: After 30 days of index procedure
Time related valve safety
Time frame: Through 30 days
Vascular and access related complications
Time frame: Pre-discharge, Through 30 days
Major vascular complications
Time frame: Pre-discharge, Through 30 days
Functional improvement from baseline as measured
Time frame: Baseline, 30 days
Echocardiographic End Points
Time frame: Through 30 days]
Patient-prosthesis Mismatch
Time frame: Through 30 days
Length of index hospital stay
Time frame: At discharge
Re-hospitalization
Time frame: Through 30 days
New onset of atrial fibrillation or atrial flutter
Time frame: Post-procedure, Pre-discharge and 30 days
Endocarditis
Time frame: Through 30 days
Major bleeding event
Time frame: Through 30 days
Myocardial rupture
Time frame: During procedure
Paravalvular Leak
Time frame: Through 30 days
Degree of over - or Under-expansion of Myval
Time frame: During Procedure
Accuracy of deployment in relation to the annular plane
Time frame: During procedure
Pacemaker deployment (and the symptoms resulting in it)
Time frame: Through 30 days
Interference with the mitral valve
Time frame: During procedure
Interference with the LVOT
Time frame: During procedure
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 4 Mar 2024.
- 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.
Ashok Thakkar, Ph.D. study chair
Head - Clinical Research and Medical Writing
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Meril Life Sciences Pvt. Ltd. at 8 sites in 7 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 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: looking for participants now, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Estonia, Italy, Netherlands, Poland and 2 more countries. 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?
Contact Ashok Thakkar, Ph.D. (+91-260-3063880 ext. 242, Ashok.Thakkar@merillife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3) (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2024.