Anchord Mitral Chordal Repair System - FIH

NCT07671820 | Not Yet Recruiting

• 1 other identifier: DMS-7096
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Incidence of device or procedure related major adverse events [Safety]

  Freedom from device- or procedure-related major adverse events.

  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.

  Day 0 - Procedure day

Secondary Outcomes (2)

• MR reduction

  30 days

• NYHA class

  90 days post procedure

Study Arms (1)

Anchord Device

EXPERIMENTAL

Anchord device implantation

Device: Anchord device implantation

Interventions

Anchord device implantation DEVICE

Anchord Mitral Chordal Repair device implantation

Anchord Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lifecord Otd: lead

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Shaily Shohat

CONTACT

+972549546605; shaily.s@life-cord.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06