Aortic Valve StenosisMATCH-BALLNCT04548726
Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis
An observational study of Aortic Valve Stenosis and Aortic Valve Regurgitation, run by Ignacio J. Amat Santos at 6 sites in 2 countries.
Trial summary
Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Despite similar mortality rates compared to surgical aortic valve replacement (SAVR) in this setting, the rate para-valvular leak (PVL) remains higher and has been… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Regurgitation
- What is being tested?
- Sapien 3 Transcather Aortic Valve Implant and Myval Transcather Aortic Valve Implant
- Type of treatment
- Medical device
- How many people
- 416 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Jun 2018to 30 Sep 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent TAVI with any of the previously explained self-expandable devices in the participating institutions and have at least one transthoracic echocardiography after TAVI procedure will be included. Main baseline and procedural characteristics as well as in-hospital outcomes will be drawn from the prospective database available at each institution. Echocardiographic exams will be centrally analysed by two independent operators blinded to the TAVI device and the clinical outcomes as well as to any clinical information of the patients. Subjects treated with each device will be matched with patients who had undergone transcatheter aortic valve implantation with the alternative devices and clinical and echocardiographic variables will be compared. The final matching will be performed by random sampling without replacement.
Who may be able to join
- All patients diagnosed with aortic stenosis (effective aortic<1.0 cm2) accepted for a TAVI procedure by the Heart Team.
- Implantation of Sapien-3 transfemoral valve or Myval transfemoral prosthesis.
- Availability of the variables selected for the matching process: Left ventricular ejection fraction, aortic annulus diameter and area, eccentricity index, and calcium score (all measured using computed tomography), body surface area, and body mass index.
- Availability of imaging studies at baseline and at discharge or 30-day follow up.
Who cannot join
- Failure to comply with matching criteria.
- Failure to properly analyse images in the echo core-lab.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Italy4 sites
Policlinico Umberto I
Roma
Policlinico Universitario Agostino Gemelli
Roma
Policlinico San Donato
San Donato Milanese
Ospedale San Raffaele
Segrate
Spain2 sites
Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas de Gran Canaria
Hospital Clínico San Carlos
Madrid
About this study
Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Despite similar mortality rates compared to surgical aortic valve replacement (SAVR) in this setting, the rate para-valvular leak (PVL) remains higher and has been associated to higher mortality even at mild degree. This is one of the major concerns to extend TAVI to low surgical risk, although the favorable results from PARTNER 3.
The presence of moderate to severe PVL after TAVI is associated to a 2- and 3- fold increase in the mortality rate at 30-day and 1-year follow-up, respectively (24-29).
Read more
Prosthesis-patient mismatch (PPM) adversely affects functional improvement and exercise tolerance, left ventricular (LV) mass regression, and late structural valve deterioration. Many studies have previously investigated PPM after surgical AVR suggesting the presence of this problem in more than 40% of the surgically treated patients. This rate was significantly lower with the balloon-expandable Sapien (Edwards Lifesciences, Irvine, California), with PPM that varied from 8% to 18%, but in both cases (patients harboring TAVI and those with SAVR) the mortality rate was higher in the presence of PPM.
Under the hypothesis that there are differences in terms of transvalvular gradients and residual para-valvular leak amongst different balloon-expandable TAVI devices available in the market, the aim of the MATCH-BALL study is to compare the hemodynamic performance of two balloon-expandable TAVI devices, Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Myval (Meril Life Sciences Pvt. Ltd., India).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation
- Being tested
- Sapien 3 Transcather Aortic Valve Implant, Myval Transcather Aortic Valve Implant
- Keywords
- TAVI, TAVR, Balloon-Expandable transcatheter heart valve
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sapien 3 Transcather Aortic Valve ImplantDevice
Implant of a Ballon Expandable Aortic Valve Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) prosthesis via a transcatheter procedure.
Myval Transcather Aortic Valve ImplantDevice
Implant of a Ballon Expandable Aortic Valve Myval (Meril Life Sciences Pvt. Ltd., India) prosthesis via a transcatheter procedure.
| Study group | Role | What they receive |
|---|---|---|
| Sapien 3 | Patients with aortic stenosis treated with Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) TAVI Receives: Device: Sapien 3 Transcather Aortic Valve Implant | |
| Myval | Patients with aortic stenosis treated with Myval (Meril Life Sciences Pvt. Ltd., India) TAVI Receives: Device: Myval Transcather Aortic Valve Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean transvalvular gradients
Mean Gradients measured in doppler echography are calculated based on the mean velocity of the tracing. The velocities are converted to pressure gradients using the Bernoulli equation.
Measured: 30 days
Aortic valve area
Echography measured Aortic valve area
Measured: 30 days
Aortic valve perivalvular leak
Echography measured perivalvular leak
Measured: 30 days
Aortic valve central leak
Echography measured central leak
Measured: 30 days
Aortic valve global leak
Echography measured global leak
Measured: 30 days
Secondary outcomes (10)
Cardiovascular mortality rate
Measured: 30 days
All-cause mortality rate
Measured: 30 days
Myocardial infarction rate
Measured: 30 days
Bleeding complications rate
Measured: 30 days
Acute kidney injury rate
Measured: 30 days
Vascular complications rate
Measured: 30 days
Conduction disorder rate
Measured: 30 days
Re-hospitalization rate
Measured: 30 days
Need for permanent pacemaker rate
Measured: 30 days
New York Heart Association (NYHA) functional class
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Jun 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ignacio J. Amat Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ignacio J. Amat Santos, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548726
- Sponsor's protocol ID
- MATCH-BALL
- Acronym
- MATCH-BALL
- Status last verified
- Jan 2021
- First submitted
- 1 Sep 2020
- Last updated
- 28 Jan 2021
- 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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04548726
- Acronym / sponsor ID
- MATCH-BALL / MATCH-BALL
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation
- Keywords
- TAVI, TAVR, Balloon-Expandable transcatheter heart valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Ignacio J. Amat SantosUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 14 Sep 2020 (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.
Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Despite similar mortality rates compared to surgical aortic valve replacement (SAVR) in this setting, the rate para-valvular leak (PVL) remains higher and has been associated to higher mortality even at mild degree. This is one of the major concerns to extend TAVI to low surgical risk, although the favorable results from PARTNER 3.
The presence of moderate to severe PVL after TAVI is associated to a 2- and 3- fold increase in the mortality rate at 30-day and 1-year follow-up, respectively (24-29).
Prosthesis-patient mismatch (PPM) adversely affects functional improvement and exercise tolerance, left ventricular (LV) mass regression, and late structural valve deterioration. Many studies have previously investigated PPM after surgical AVR suggesting the presence of this problem in more than 40% of the surgically treated patients. This rate was significantly lower with the balloon-expandable Sapien (Edwards Lifesciences, Irvine, California), with PPM that varied from 8% to 18%, but in both cases (patients harboring TAVI and those with SAVR) the mortality rate was higher in the presence of PPM.
Under the hypothesis that there are differences in terms of transvalvular gradients and residual para-valvular leak amongst different balloon-expandable TAVI devices available in the market, the aim of the MATCH-BALL study is to compare the hemodynamic performance of two balloon-expandable TAVI devices, Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Myval (Meril Life Sciences Pvt. Ltd., India).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sapien 3 | – | Device: Sapien 3 Transcather Aortic Valve ImplantPatients with aortic stenosis treated with Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) TAVI |
| Myval | – | Device: Myval Transcather Aortic Valve ImplantPatients with aortic stenosis treated with Myval (Meril Life Sciences Pvt. Ltd., India) TAVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent TAVI with any of the previously explained self-expandable devices in the participating institutions and have at least one transthoracic echocardiography after TAVI procedure will be included. Main baseline and procedural characteristics as well as in-hospital outcomes will be drawn from the prospective database available at each institution. Echocardiographic exams will be centrally analysed by two independent operators blinded to the TAVI device and the clinical outcomes as well as to any clinical information of the patients. Subjects treated with each device will be matched with patients who had undergone transcatheter aortic valve implantation with the alternative devices and clinical and echocardiographic variables will be compared. The final matching will be performed by random sampling without replacement.
Key inclusion criteria (4 listed)
- All patients diagnosed with aortic stenosis (effective aortic<1.0 cm2) accepted for a TAVI procedure by the Heart Team.
- Implantation of Sapien-3 transfemoral valve or Myval transfemoral prosthesis.
- Availability of the variables selected for the matching process: Left ventricular ejection fraction, aortic annulus diameter and area, eccentricity index, and calcium score (all measured using computed tomography), body surface area, and body mass index.
- Availability of imaging studies at baseline and at discharge or 30-day follow up.
Key exclusion criteria (2 listed)
- Failure to comply with matching criteria.
- Failure to properly analyse images in the echo core-lab.
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 |
|---|---|---|
| Sapien 3 Transcather Aortic Valve ImplantImplant of a Ballon Expandable Aortic Valve Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) prosthesis via a transcatheter procedure. | Device | Sapien 3 |
| Myval Transcather Aortic Valve ImplantImplant of a Ballon Expandable Aortic Valve Myval (Meril Life Sciences Pvt. Ltd., India) prosthesis via a transcatheter procedure. | Device | Myval |
Primary outcome
Mean transvalvular gradients
Time frame: 30 days
Mean Gradients measured in doppler echography are calculated based on the mean velocity of the tracing. The velocities are converted to pressure gradients using the Bernoulli equation.
Aortic valve area
Time frame: 30 days
Echography measured Aortic valve area
Aortic valve perivalvular leak
Time frame: 30 days
Echography measured perivalvular leak
Aortic valve central leak
Time frame: 30 days
Echography measured central leak
Aortic valve global leak
Time frame: 30 days
Echography measured global leak
10 secondary outcomes
Cardiovascular mortality rate
Time frame: 30 days
All-cause mortality rate
Time frame: 30 days
Myocardial infarction rate
Time frame: 30 days
Bleeding complications rate
Time frame: 30 days
Acute kidney injury rate
Time frame: 30 days
Vascular complications rate
Time frame: 30 days
Conduction disorder rate
Time frame: 30 days
Re-hospitalization rate
Time frame: 30 days
Need for permanent pacemaker rate
Time frame: 30 days
New York Heart Association (NYHA) functional class
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Aortic Valve Regurgitation, run by Ignacio J. Amat Santos at 6 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 4 inclusion and 2 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean transvalvular gradients (time frame: 30 days). The study lists 5 primary outcomes in all. 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 28 Jan 2021.