NCT03581656

Brief Summary

The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.

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
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

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

March 21, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

5.5 years

First QC Date

June 4, 2018

Last Update Submit

July 9, 2022

Conditions

Mitral Valve RepairMitral RegurgitationMitral Valve Insufficiency

Keywords

Degenerative Mitral Leaflet ProlapseHeart DiseaseMinimally Invasive

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    The frequency of all-cause mortality

    At 30 days from implant procedure

  • Major adverse events

    The frequency of pre-determined major adverse events

    At 30 days from implant procedure

Secondary Outcomes (2)

  • Technical Success

    End of Implantation Procedure

  • Device Performance

    At 30 days

Study Arms (1)

Arm

EXPERIMENTAL

The ChordArt System is intended for chordal replacement in patients with mitral valve insufficiency due to leaflet prolapse or flail delivered through a catheter based technology for mitral chordal replacement via a small incision in the thorax.

Device: ChordArt System

Interventions

ChordArt SystemDEVICE

The ChordArt System is intended for chordal replacement in mitral valve insufficiency due to leaflet prolapse or flail. One or more ChordArt System may be utilized within the same intervention for optimal mitral valve treatment.

Arm

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail
  • Left Ventricular Ejection Fraction \>20%
  • New York Heart Association functional class II to IV
  • Able and willing to give informed consent and follow protocol procedures.

You may not qualify if:

  • Life expectancy \<1 year
  • Hemodynamic instability
  • Severe untreated ischemic disease
  • Pulmonary Hypertension
  • Any prior mitral valve surgery or transcatheter mitral valve procedure
  • Stroke or transient ischemic event within 30 days before randomization
  • Patient is pregnant (urine human chorionic gonadotropin (HCG) test result positive), planning to be pregnant or lactating.
  • Renal insufficiency
  • Acute anemia
  • Chronic obstructive pulmonary disease
  • Severe right ventricular dysfunction
  • Hepatic insufficiency
  • Patient is participating in other investigational studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08410, Lithuania

Location

Related Publications (2)

  • Mohty D, Orszulak TA, Schaff HV, Avierinos JF, Tajik JA, Enriquez-Sarano M. Very long-term survival and durability of mitral valve repair for mitral valve prolapse. Circulation. 2001 Sep 18;104(12 Suppl 1):I1-I7. doi: 10.1161/hc37t1.094903.

    PMID: 11568020BACKGROUND

  • Urbanski PP. Modified technique of chordal replacement for mitral valve repair. Thorac Cardiovasc Surg. 2005 Oct;53(5):315-7. doi: 10.1055/s-2005-865685.

    PMID: 16208620BACKGROUND

Related Links

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Diseases

Condition Hierarchy (Ancestors)

Heart Valve DiseasesCardiovascular Diseases

Study Officials

  • Kestutis Rucinskas, MD

    Heart Surgery Centre, Santariskiu Vilnius

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm, multi-center, prospective, non-randomized study. The study is conducted in accordance with the guidelines of the Mitral Valve Academic Research Consortium (MVARC) regarding study design and endpoint definition as well as International Standards Organization 5840-3.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2018

First Posted

July 10, 2018

Study Start

March 21, 2018

Primary Completion

September 10, 2023

Study Completion

December 1, 2023

Last Updated

July 12, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)