Health TrialsbyHealthPanel

Anchord Mitral Chordal Repair System - FIH

ConditionMitral Regurgitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLifecord Otd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Active endocarditis or systemic infection

Severe left ventricular dysfunction (LVEF <30%)

Significant non-mitral valvular disease requiring intervention

Severe mitral annular calcification (MAC)

Trial design

Design model

Single group

Treatments tested in this trial

  • Anchord device implantation

    Device

    Anchord Mitral Chordal Repair device implantation

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Anchord DeviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
30 days post-procedure.
2

Number of Successful device implantation assessed by imaging [Technical Success]

Successful delivery, deployment, and secure fixation of the device assessed during the procedure.

Time frame
Day 0 - Procedure day

Secondary outcomes

1

MR reduction

Mitral regurgitation reduction of 1 or more degrees

Time frame
30 days
2

NYHA class

Improvement in NYHA functional by 1 or more degrees

Time frame
90 days post procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lifecord Otd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: