Menu
Not yet recruiting NCT07671820

Anchord Mitral Chordal Repair System - FIH

No phase Interventional Mitral Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anchord device implantation.
Who it may be relevant to
Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Anchord Mitral Chordal Repair System for Patients With Degenerative Mitral Regurgitation

Overview

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.

Interventions

  • Device Anchord device implantation
    Anchord Mitral Chordal Repair device implantation

Primary outcome measures

  • Incidence of device or procedure related major adverse events [Safety] [Time frame: 30 days post-procedure.]
  • Number of Successful device implantation assessed by imaging [Technical Success] [Time frame: Day 0 - Procedure day]
Secondary outcome measures (2)
  • MR reduction [Time frame: 30 days]
  • NYHA class [Time frame: 90 days post procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07671820 · DMS-7096

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗