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Mi-STITCH™ and Mi-KNOT™ Device Technologies - Improvement of Mitral Valve Repair

NCT05034471 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-12-08

No results posted yet for this study

Summary

The objective of this study is to analyze the safety and efficacy of a novel device for minimally invasive mitral valve repair. Data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.

Conditions

  • Mitral Regurgitation
  • Mitral Valve Insufficiency

Interventions

DEVICE

Mi-Chord™ Device Technologies

Mi-Chord™ System consists of LS-5™ ePTFE suture, the Mi-STITCH™ suturing device, the Mi-KNOT™ device and the Mi-KNOT™ titanium fastener. Mi-Chord™ system is designed to replace the chordae tendineae in order to enable mitral valve repair. These sub-devices (ePTFE suture, Mi-STITCH™, Mi-KNOT™ device, Mi-KNOT™ titanium fastener) can be considered as one system and refer to different aspects of the overall technology.

Sponsors & Collaborators

  • LSI SOLUTIONS, Inc.

    collaborator UNKNOWN

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Martin Andreas, MD, PhD, MBA · Department of Cardiac Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-05
Primary Completion
2022-03-31
Completion
2023-04-30
FDA Device
Yes

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05034471 on ClinicalTrials.gov