ChordArt System for Mitral Regurgitation (CHAGALL)

July 9, 2022 updated by: CoreMedic GmbH

ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

ChordArt utilizes a minimally invasive catheter based approach by which multiple artificial chordae are precisely positioned into the papillary muscle and then secured to the pathological leaflet.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania, 08410
        • Vilnius University Hospital Santariskiu Klinikos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: At 30 days from implant procedure
The frequency of all-cause mortality
At 30 days from implant procedure
Major adverse events
Time Frame: At 30 days from implant procedure
The frequency of pre-determined major adverse events
At 30 days from implant procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: End of Implantation Procedure
The technical success will be measured by the absence of procedural mortality, successful access, delivery of the ChordArt implant & retrieval of the ChordArt delivery system as well as successful ChordArt deployment, positioning and freedom from emergency surgery or re-intervention related to the device or access procedure.
End of Implantation Procedure
Device Performance
Time Frame: At 30 days
The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography.
At 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoreMedic GmbH

Collaborators

Meditrial Europe Ltd.

Investigators

  • Principal Investigator: Kestutis Rucinskas, MD, Heart Surgery Centre, Santariskiu Vilnius

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2018

Primary Completion (Anticipated)

September 10, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 9, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-000274-001
  • CHAGALL (Other Identifier: Other Identifier)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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