Mitral Valve Regurgitation (Degenerative or Functional)NCT05263375
TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE
A study testing Innovalve TMVR system in people with Mitral Valve Regurgitation (Degenerative or Functional), run by Innovalve Bio Medical Ltd..
Trial summary
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation (Degenerative or Functional)
- What is being tested?
- Innovalve TMVR system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jun 2025
- Phase
- Interventional
- 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
Who may be able to join
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
Who cannot join
- Unsuitable anatomy
- Patient is inoperable
- EF <30%
About this study
Official title: TVMR With the Innovalve System Trial - Pilot Study in Belgium
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Being tested
- Innovalve TMVR system
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovalve TMVR systemDevice
Innovalve TMVR system
| Study group | Role | What they receive |
|---|---|---|
| MV replacement with Innovalve TMVR system | Experimental | MV replacement with Innovalve TMVR system Receives: Device: Innovalve TMVR system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with implant or delivery related serious adverse events at 30 days
Number of patients with implant or delivery related serious adverse events at 30 days
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 posted2 Mar 2022
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: Stdy never submitted to any regulatory body or never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve Regurgitation (Degenerative or Functional)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovalve Bio Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263375
- Sponsor's protocol ID
- INVL21-02-BE
- Status last verified
- Jul 2024
- First submitted
- 21 Feb 2022
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TVMR With the Innovalve System Trial - Pilot Study in Belgium
- ClinicalTrials.gov ID
- NCT05263375
- Acronym / sponsor ID
- INVL21-02-BE
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stdy never submitted to any regulatory body or never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Innovalve Bio Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 2 Mar 2022 (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.
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MV replacement with Innovalve TMVR system | Experimental | Device: Innovalve TMVR systemMV replacement with Innovalve TMVR system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
Key exclusion criteria (3 listed)
- Unsuitable anatomy
- Patient is inoperable
- EF <30%
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 |
|---|---|---|
| Innovalve TMVR systemInnovalve TMVR system | Device | MV replacement with Innovalve TMVR system |
Primary outcome
Number of patients with implant or delivery related serious adverse events at 30 days
Time frame: 30 days
Number of patients with implant or delivery related serious adverse events at 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Innovalve TMVR system in people with Mitral Valve Regurgitation (Degenerative or Functional), run by Innovalve Bio Medical Ltd..
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 3 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: withdrawn, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with implant or delivery related serious adverse events at 30 days (time frame: 30 days). 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 19 Jul 2024.