Mitral Valve Regurgitation (Degenerative or Functional)TWIST-FIHILNCT05688514
TVMR With the Innovalve System Trial - First In Human Israel
A study testing Innovalve MR system in people with Mitral Valve Regurgitation (Degenerative or Functional), run by Edwards Lifesciences at 1 site in Israel.
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 MR system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2021to 1 Apr 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<25%
Trial locations and contacts
1 site in 1 country.
About this study
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Read the detailed description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Being tested
- Innovalve MR 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 MR systemDevice
Innovalve MR system
| Study group | Role | What they receive |
|---|---|---|
| Innovalve TMVR System | Experimental | MV replacement with Innovalve MR system Receives: Device: Innovalve MR system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of implant or delivery related serious adverse events at 30 days
Absence of implant or delivery related serious adverse events
Measured: 30 days
Secondary outcomes (6)
Technical success
All of the below:
- Absence of procedural mortality; and ii. Successful access, delivery, and retrieval of the device delivery system; and iii. Successful deployment and correct positioning of the first intended device; and iv. Freedom from emergency surgery or reintervention related to the device or access procedure.
Measured: Procedure
Procedural success
All of the following must be present:
- Deployment of the device
II. Absence of major device or procedure related serious adverse events, including:
- Death
- Stroke
- Life-threatening bleeding (MVARC scale)
- Major vascular complications
- Major cardiac structural complications
- Stage 2 or 3 acute kidney injury (includes new dialysis)
- Myocardial infarction or coronary ischemia requiring PCI or CABG
- Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for 48 h.
- Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Measured: 30 days
NYHA functional class
Measured: 30 days, 6, 12 months and annually up to 5 years
Six-minute walk test
Measured: 30 days, 6, 12 months and annually up to 5 years
Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire
Measured: 30 days, 6, 12 months and annually up to 5 years
Reduction in Mitral Regurgitation grade
Measured: 30 days, 6, 12 months and annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Oct 2021
- Primary completion6 Oct 2021
- Study completion1 Apr 2025
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.
- 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
- 1 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
- NCT05688514
- Sponsor's protocol ID
- INVL20-01-IL
- Acronym
- TWIST-FIHIL
- Status last verified
- Apr 2025
- First submitted
- 22 Dec 2022
- Last updated
- 23 Apr 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 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TVMR With the Innovalve System Trial - First In Human Israel
- ClinicalTrials.gov ID
- NCT05688514
- Acronym / sponsor ID
- TWIST-FIHIL / INVL20-01-IL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 18 Jan 2023 (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
Detailed description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility 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 |
|---|---|---|
| Innovalve TMVR System | Experimental | Device: Innovalve MR systemMV replacement with Innovalve MR 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<25%
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 MR systemInnovalve MR system | Device | Innovalve TMVR System |
Primary outcome
Absence of implant or delivery related serious adverse events at 30 days
Time frame: 30 days
Absence of implant or delivery related serious adverse events
6 secondary outcomes
Technical success
Time frame: Procedure
Procedural success
Time frame: 30 days
NYHA functional class
Time frame: 30 days, 6, 12 months and annually up to 5 years
Six-minute walk test
Time frame: 30 days, 6, 12 months and annually up to 5 years
Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire
Time frame: 30 days, 6, 12 months and annually up to 5 years
Reduction in Mitral Regurgitation grade
Time frame: 30 days, 6, 12 months and annually up to 5 years
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 23 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovalve MR system in people with Mitral Valve Regurgitation (Degenerative or Functional), run by Edwards Lifesciences at 1 site in Israel.
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: finished, as of the sponsor's last update on 23 Apr 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 Israel. 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?
Absence of 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 23 Apr 2025.