ClinicalTrials.gg
Not yet recruitingNCT07912229Updated Nov 3, 2026

Early Feasibility Study of NeoChord Transcatheter Mitral Repair System

An interventional study of Transcatheter Chordal Repair in Degenerative Mitral Regurgitation and Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse, sponsored by NeoChord. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by NeoChord · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Degenerative Mitral Regurgitation
  • Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse

Keywords

  • NeoChord
  • Vincora
  • Chordal Repair
  • Mitral Repair
03

In context

Mitral Valve Insufficiency

468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.

This study's planned enrollment of 15 is below the median of 68 across 279 interventional studies indexed under Mitral Valve Insufficiency.

Browse Mitral Valve Insufficiency studies →

Lead sponsor

NeoChord is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Subject age ≥ 18-85 years at time of enrollment.
  2. Symptomatic MR > 3+ confirmed by echocardiographic core lab.
  3. 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.
  4. (LVEF) is ≥30% (within 180 days prior to subject enrollment based upon TTE).
  5. Cardiac symptoms present ( Functional Class II, III, or ambulatory IVa) and a candidate for primary MR surgical repair (based on anatomical criteria).
  6. 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.

Key Exclusion Criteria:

  1. MR etiology that is exclusively Secondary (functional).
  2. Echocardiographic evidence of EROA ≤ 0.3cm2.
  3. Untreated coronary artery disease requiring revascularization.
  4. Aortic, pulmonary, or tricuspid valve disease which is severe or greater, or requiring surgery.
  5. Any prior mitral valve surgery or transcatheter mitral valve procedure.
  6. Stroke, transient ischemic event, or myocardial infarction within 30 Days prior to index procedure.
  7. Active endocarditis.
  8. Pregnant or planning pregnancy within next 12 months.
  9. \<1 year due to non-cardiac conditions including cancer.
  10. Prior orthotropic heart transplant.
  11. Currently participating in another drug or device study and has not reached primary endpoint.
  12. Known allergy or to nickel, titanium or contrast dye or to procedural or post procedural medications (example aspirin, clopidogrel, heparin) which cannot be adequately managed medically.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Device: NeXus Transcatheter Mitral Repair System

    Device: Transcatheter Chordal Repair

Interventions

  • DeviceTranscatheter Chordal Repair

    Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation Due to Chordal Elongation or Rupture Resulting in Mitral Valve Prolapse

06

What researchers measure

Primary outcomes

  1. Primary Endpoint

    Major Device Related Adverse Events through thirty (30) days

    Time frame: 30 Days

Secondary outcomes

  1. Technical Sucess

    Successful access, delivery, and deployment

    Time frame: Procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Feasibility Stage

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for Feb 2029, 24 months later.

Of 90 industry-sponsored interventional studies with no phase under Mitral Valve Insufficiency, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 144. This study's planned 24 months is below that.

Counting every sponsor, half of 143 studies reached it within 56 months; a quarter within 25 and three quarters within 108.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 3, 2026
StartEst.
Feb 20, 2027
Primary completionEst.
Feb 20, 2029
CompletionEst.
Feb 20, 2032
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07912229
Lead sponsor
NeoChord
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Feb 20, 2027 (estimated)
Primary completion
Feb 20, 2029 (estimated)
Completion
Feb 20, 2032 (estimated)
Last update
Nov 3, 2026

Study contacts

Kavitha Ganesan
Contact
kganesan@neochord.com
8646508861

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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