NCT05034471

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

August 13, 2021

Last Update Submit

December 6, 2021

Conditions

Mitral RegurgitationMitral Valve Insufficiency

Keywords

minimal invasive surgerynovel surgical devicemitral valve repaircardiac surgery

Outcome Measures

Primary Outcomes (2)

  • Primary safety endpoint - 30day Mortality

    30 day Mortality

    30 days

  • Primary efficacy endpoint - Implantation Time

    Defined as the period from start of valve assessment until the completion of the repair

    intraoperative

Secondary Outcomes (3)

  • Secondary safety endpoints - Mortality

    1, 6 and 12 months

  • Secondary safety endpoints - Rate of SAEs

    1, 6 and 12 months

  • Secondary efficacy endpoints - Procedural times

    intraoperative

Other Outcomes (1)

  • Residual mitral valve regurgitation

    1 and 6 months

Study Arms (1)

Mitral Valve Repair with Novel Device Technologies

EXPERIMENTAL

All study participants will undergo mitral valve repair by replacing the chordae tendinea with ePTFE single loop sutures using novel suturing devices.

Device: Mi-Chord™ Device Technologies

Interventions

Mi-Chord™ Device TechnologiesDEVICE

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.

Mitral Valve Repair with Novel Device Technologies

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe primary mitral valve regurgitation according to current guidelines with indication for mitral valve repair
  • Euroscore II \< 8
  • Left ventricle ejection fraction \> 35%
  • Life expectancy above 1 year after the intervention based on operator assessment
  • Willing to sign informed consent
  • Willing to undergo all medical follow-ups necessary for the clinical investigations until study termination (echocardiography, blood tests, physical investigation)

You may not qualify if:

  • Age \<18 years
  • Active endocarditis or myocarditis
  • Previous cardiac surgery
  • Heavily calcified mitral valve annulus
  • Severe mitral stenosis
  • Female pregnant patients
  • Emergency procedures
  • Patient not able to read or understand informed consent
  • Patient not willing to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Martin Andreas, MD, PhD, MBA

    Department of Cardiac Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Andreas, MD, PhD, MBA

CONTACT

+43 1 40400 52620martin.andreas@meduniwien.ac.at

Paul Werner, MD

CONTACT

+43 1 40400 52620paul.werner@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr. Martin ANDREAS, MBA, PhD, MEBCTS

Study Record Dates

First Submitted

August 13, 2021

First Posted

September 5, 2021

Study Start

August 5, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2023

Last Updated

December 8, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)