Mitral RegurgitationNCT07671820
Anchord Mitral Chordal Repair System - FIH
A study testing Anchord device implantation in people with Mitral Regurgitation, run by Lifecord Otd.
Trial summary
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal Repair System in patients with degenerative mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Anchord device implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Severe symptomatic degenerative mitral regurgitation (grade 3+)
- High surgical risk for open-heart mitral valve repair or replacement
- Suitable anatomy for transcatheter chordal repair as determined by the treating physician
- Ability to undergo required echocardiographic and fluoroscopic imaging
- Ability to provide informed consent
Who cannot join
- Active endocarditis or systemic infection
- Severe left ventricular dysfunction (LVEF <30%)
- Significant non-mitral valvular disease requiring intervention
- Severe mitral annular calcification (MAC)
- Presence of intracardiac or femoral venous thrombus or thrombus in the inferior vena cava
- Cerebrovascular events (TIA, CVA) or thromboembolic events within the previous 6 months.
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- Renal insufficiency
- Inability to undergo required imaging or access
- Inability to tolerate standard anticoagulation or antithrombotic regimen
- Rheumatic mitral valve disease
- Co-morbid condition limiting life expectancy or study completion
- Pregnancy
- Participation in another clinical trial
- Previous device treatment for MR.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Anchord Mitral Chordal Repair System for Patients With Degenerative Mitral Regurgitation
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal Repair System in patients with degenerative mitral regurgitation. The main question[s] it aims to answer are to assess the safety of procedure, the reduction in mitral regurgitation severity and changes in hemodynamic and symptomatic status.
Participants will be implanted with the Anchord device.
- Conditions
- Mitral Regurgitation
- Being tested
- Anchord device implantation
- 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.
Anchord device implantationDevice
Anchord Mitral Chordal Repair device implantation
| Study group | Role | What they receive |
|---|---|---|
| Anchord Device | Experimental | Anchord device implantation Receives: Device: Anchord device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device or procedure related major adverse events [Safety]
Freedom from device- or procedure-related major adverse events.
Measured: 30 days post-procedure.
Number of Successful device implantation assessed by imaging [Technical Success]
Successful delivery, deployment, and secure fixation of the device assessed during the procedure.
Measured: Day 0 - Procedure day
Secondary outcomes (2)
MR reduction
Mitral regurgitation reduction of 1 or more degrees
Measured: 30 days
NYHA class
Improvement in NYHA functional by 1 or more degrees
Measured: 90 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifecord Otd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671820
- Sponsor's protocol ID
- DMS-7096
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2026
- Last updated
- 4 Sep 2026
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anchord Mitral Chordal Repair System for Patients With Degenerative Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT07671820
- Acronym / sponsor ID
- DMS-7096
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Lifecord OtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Jun 2026 (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.
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal Repair System in patients with degenerative mitral regurgitation. The main question[s] it aims to answer are to assess the safety of procedure, the reduction in mitral regurgitation severity and changes in hemodynamic and symptomatic status.
Participants will be implanted with the Anchord device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anchord Device | Experimental | Device: Anchord device implantationAnchord device implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe symptomatic degenerative mitral regurgitation (grade 3+)
- High surgical risk for open-heart mitral valve repair or replacement
- Suitable anatomy for transcatheter chordal repair as determined by the treating physician
- Ability to undergo required echocardiographic and fluoroscopic imaging
- Ability to provide informed consent
Key exclusion criteria (14 listed)
- Active endocarditis or systemic infection
- Severe left ventricular dysfunction (LVEF <30%)
- Significant non-mitral valvular disease requiring intervention
- Severe mitral annular calcification (MAC)
- Presence of intracardiac or femoral venous thrombus or thrombus in the inferior vena cava
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 |
|---|---|---|
| Anchord device implantationAnchord Mitral Chordal Repair device implantation | Device | Anchord Device |
Primary outcome
Incidence of device or procedure related major adverse events [Safety]
Time frame: 30 days post-procedure.
Freedom from device- or procedure-related major adverse events.
Number of Successful device implantation assessed by imaging [Technical Success]
Time frame: Day 0 - Procedure day
Successful delivery, deployment, and secure fixation of the device assessed during the procedure.
2 secondary outcomes
MR reduction
Time frame: 30 days
NYHA class
Time frame: 90 days post 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 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Anchord device implantation in people with Mitral Regurgitation, run by Lifecord Otd.
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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 4 Sep 2026. 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?
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 Shaily Shohat (+972549546605, shaily.s@life-cord.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device or procedure related major adverse events [Safety] (time frame: 30 days post-procedure.). The study lists 2 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 4 Sep 2026.