Aortic Valve StenosisGerman MYVAL SNCT06804148
MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry
An observational study of Aortic Valve Stenosis, run by Prof. Dr. med. Ingo Eitel at 1 site in Germany.
Trial summary
Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV. 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
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2025to 30 Dec 2030
- 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: Patients who will be treated with Myval TAVR are included in the registry.
Who may be able to join
- Patient is going to be treated with Myval THV
- Age ≥ 18 years
- Ability to give informed consent
Who cannot join
- Pregnant and lactating women
- Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
- Patients in whom anti-platelet and/or anticoagulant therapy are contra-indicated.
- Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christian Frerker, PD Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, 23538
Christian Frerker, PD Dr., 045150044542, CVRO@uksh.de
About this study
Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Myval Transcatheter Heart Valve
- 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 ValveDevice
The Myval TAVR bioprothesis is a balloon-expandable THV developed by Meril Lifesciences, which has novel operator friendly design features to improve deliverability and aid precise deployment.
What is being measured
The primary outcome is the main question the study is designed to answer.
It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation
Measured: 5 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Jan 2025
- Primary completion1 Dec 2030 (estimated)
- Study completion30 Dec 2030 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Ingo Eitel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Ingo Eitel, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804148
- Sponsor's protocol ID
- 2024-500
- Acronym
- German MYVAL S
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry
- ClinicalTrials.gov ID
- NCT06804148
- Acronym / sponsor ID
- German MYVAL S / 2024-500
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Ingo EitelUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 3 Feb 2025 (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.
Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be treated with Myval TAVR are included in the registry.
Key inclusion criteria (3 listed)
- Patient is going to be treated with Myval THV
- Age ≥ 18 years
- Ability to give informed consent
Key exclusion criteria (4 listed)
- Pregnant and lactating women
- Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
- Patients in whom anti-platelet and/or anticoagulant therapy are contra-indicated.
- Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the registry
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 ValveThe Myval TAVR bioprothesis is a balloon-expandable THV developed by Meril Lifesciences, which has novel operator friendly design features to improve deliverability and aid precise deployment. | Device | – |
Primary outcome
It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation
Time frame: 5 Year
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 3 Feb 2025.
- 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.
Christian Frerker, PD Dr. contact
1 site in 1 country: 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 Prof. Dr. med. Ingo Eitel at 1 site in Germany.
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 3 inclusion and 4 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Ingo Eitel, Prof. Dr. (004945150044542, cvro@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation (time frame: 5 Year). 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 3 Feb 2025.