Anchord Mitral Chordal Repair System - FIH

June 23, 2026 updated by: Lifecord Otd

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anchord Device
Anchord device implantation
Device: Anchord device implantation
Anchord Mitral Chordal Repair device implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days post-procedure.
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.
Day 0 - Procedure day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MR reduction
Time Frame: 30 days
Mitral regurgitation reduction of 1 or more degrees
30 days
NYHA class
Time Frame: 90 days post procedure
Improvement in NYHA functional by 1 or more degrees
90 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lifecord Otd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMS-7096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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