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NCT Number: NCT07671820

Anchord Mitral Chordal Repair System - FIH

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Anchord device implantation

Device

Anchord Mitral Chordal Repair device implantation

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. MR reduction

    Time frame: 30 days

    Mitral regurgitation reduction of 1 or more degrees

  2. NYHA class

    Time frame: 90 days post procedure

    Improvement in NYHA functional by 1 or more degrees

Study contacts

Contact information is provided by the study sponsor or research team.

Shaily Shohat

CONTACT

[email protected]

+972549546605

Sponsors and collaborators

Lead sponsor

Lifecord Otd

Industry

Registry information

Official study title

Anchord Mitral Chordal Repair System for Patients With Degenerative Mitral Regurgitation

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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