Degenerative Mitral RegurgitationNCT07912229
Early Feasibility Study of NeoChord Transcatheter Mitral Repair System
A study testing Transcatheter Chordal Repair in people with Degenerative Mitral Regurgitation and Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse, run by NeoChord.
Trial summary
Safety and performance evaluation of Transcatheter Mitral Repair System in subjects with moderate to severe (>3+) degenerative mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Mitral Regurgitation, Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
- What is being tested?
- Transcatheter Chordal Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2027to 20 Feb 2032
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject age ≥ 18-85 years at time of enrollment.
- Symptomatic MR > 3+ confirmed by echocardiographic core lab.
- Primary segmental prolapse or flail of P2 segment only, or P2 segmental prolapse or flail extending to one adjacent segment (P1 or P3), and the primary regurgitant jet is non- commissural.
- Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 180 days prior to subject enrollment based upon TTE).
- Cardiac symptoms present (NYHA Functional Class II, III, or ambulatory IVa) and a candidate for primary MR surgical repair (based on anatomical criteria).
- Intermediate or high surgical risk based on per MVARC guidelines as determined by the site Heart Team and adjudicated by the Subject Screening Committee based.
Who cannot join
- MR etiology that is exclusively Secondary (functional).
- Echocardiographic evidence of EROA ≤ 0.3cm2.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Aortic, pulmonary, or tricuspid valve disease which is severe or greater, or requiring surgery.
- Any prior mitral valve surgery or transcatheter mitral valve procedure.
- Stroke, transient ischemic event, or myocardial infarction within 30 Days prior to index procedure.
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- Active endocarditis.
- Pregnant or planning pregnancy within next 12 months.
- Life expectancy <1 year due to non-cardiac conditions including cancer.
- Prior orthotropic heart transplant.
- Currently participating in another investigational drug or device study and has not reached primary endpoint.
- Known allergy or hypersensitivity to nickel, titanium or contrast dye or contraindication to procedural or post procedural medications (example aspirin, clopidogrel, heparin) which cannot be adequately managed medically.
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: Early Feasibility Study of the NeoChord Transcatheter Mitral Repair System in Patients With Primary Mitral Regurgitation
Safety and performance evaluation of Transcatheter Mitral Repair System in subjects with moderate to severe (>3+) degenerative mitral regurgitation.
Read the detailed description
The objective of this Early Feasibility Study (EFS) is to assess the safety and performance of the NeoChord Transcatheter Mitral Repair System in treating subjects with mitral regurgitation who are at intermediate or high risk for standard mitral valve surgery.
- Conditions
- Degenerative Mitral Regurgitation, Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
- Being tested
- Transcatheter Chordal Repair
- Keywords
- NeoChord, Vincora, Chordal Repair, Mitral Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Chordal RepairDevice
Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation Due to Chordal Elongation or Rupture Resulting in Mitral Valve Prolapse
| Study group | Role | What they receive |
|---|---|---|
| Device: NeXus Transcatheter Mitral Repair System | Experimental | Not described Receives: Device: Transcatheter Chordal Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Major Device Related Adverse Events through thirty (30) days
Measured: 30 Days
Secondary outcomes (1)
Technical Sucess
Successful access, delivery, and deployment
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start20 Feb 2027 (estimated)
- Primary completion20 Feb 2029 (estimated)
- Study completion20 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeoChord
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912229
- Sponsor's protocol ID
- PR-610750-001
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Feasibility Stage
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the NeoChord Transcatheter Mitral Repair System in Patients With Primary Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT07912229
- Acronym / sponsor ID
- PR-610750-001
- Conditions
- Degenerative Mitral Regurgitation, Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
- Keywords
- NeoChord, Vincora, Chordal Repair, Mitral Repair
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- NeoChordIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2027 (estimated)
- Primary completion
- 20 Feb 2029 (estimated)
- Study completion
- 20 Feb 2032 (estimated)
- First posted
- 3 Nov 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.
Safety and performance evaluation of Transcatheter Mitral Repair System in subjects with moderate to severe (>3+) degenerative mitral regurgitation.
Detailed description
The objective of this Early Feasibility Study (EFS) is to assess the safety and performance of the NeoChord Transcatheter Mitral Repair System in treating subjects with mitral regurgitation who are at intermediate or high risk for standard mitral valve surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: NeXus Transcatheter Mitral Repair System | Experimental | Device: Transcatheter Chordal Repair |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject age ≥ 18-85 years at time of enrollment.
- Symptomatic MR > 3+ confirmed by echocardiographic core lab.
- Primary segmental prolapse or flail of P2 segment only, or P2 segmental prolapse or flail extending to one adjacent segment (P1 or P3), and the primary regurgitant jet is non- commissural.
- Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 180 days prior to subject enrollment based upon TTE).
- Cardiac symptoms present (NYHA Functional Class II, III, or ambulatory IVa) and a candidate for primary MR surgical repair (based on anatomical criteria).
Key exclusion criteria (12 listed)
- MR etiology that is exclusively Secondary (functional).
- Echocardiographic evidence of EROA ≤ 0.3cm2.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Aortic, pulmonary, or tricuspid valve disease which is severe or greater, or requiring surgery.
- Any prior mitral valve surgery or transcatheter mitral valve procedure.
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 |
|---|---|---|
| Transcatheter Chordal RepairTranscatheter Mitral Valve Repair for Degenerative Mitral Regurgitation Due to Chordal Elongation or Rupture Resulting in Mitral Valve Prolapse | Device | Device: NeXus Transcatheter Mitral Repair System |
Primary outcome
Primary Endpoint
Time frame: 30 Days
Major Device Related Adverse Events through thirty (30) days
1 secondary outcome
Technical Sucess
Time frame: 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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided. Feasibility Stage
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FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
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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 Transcatheter Chordal Repair in people with Degenerative Mitral Regurgitation and Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse, run by NeoChord.
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 6 inclusion and 12 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 3 Nov 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 Kavitha Ganesan (8646508861, kganesan@neochord.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (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 3 Nov 2026.