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ChordArt System for Mitral Regurgitation (CHAGALL)

Primary Purpose

Mitral Valve Repair, Mitral Regurgitation, Mitral Valve Insufficiency

Status

Active

Phase

Not Applicable

Locations

Lithuania

Study Type

Interventional

Intervention

ChordArt System

About this trial

This is an interventional treatment trial for Mitral Valve Repair focused on measuring Degenerative Mitral Leaflet Prolapse, Heart Disease, Minimally Invasive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vilnius University Hospital Santariskiu Klinikos

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

All-cause mortality

The frequency of all-cause mortality

Major adverse events

The frequency of pre-determined major adverse events

Secondary Outcome Measures

Technical Success

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.

Device Performance

The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography.

Full Information

NCT ID

NCT03581656

First Posted

June 4, 2018

Last Updated

July 9, 2022

Sponsor

CoreMedic GmbH

Collaborators

Meditrial Europe Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03581656

Brief Title

ChordArt System for Mitral Regurgitation

Acronym

CHAGALL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 21, 2018 (Actual)

Primary Completion Date

September 10, 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CoreMedic GmbH

Collaborators

Meditrial Europe Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Repair, Mitral Regurgitation, Mitral Valve Insufficiency

Keywords

Degenerative Mitral Leaflet Prolapse, Heart Disease, Minimally Invasive

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

ChordArt System

Intervention Description

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.

Primary Outcome Measure Information:

Title

All-cause mortality

Description

The frequency of all-cause mortality

Time Frame

At 30 days from implant procedure

Title

Major adverse events

Description

The frequency of pre-determined major adverse events

Time Frame

At 30 days from implant procedure

Secondary Outcome Measure Information:

Title

Technical Success

Description

Time Frame

End of Implantation Procedure

Title

Device Performance

Description

The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography.

Time Frame

At 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kestutis Rucinskas, MD

Organizational Affiliation

Heart Surgery Centre, Santariskiu Vilnius

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vilnius University Hospital Santariskiu Klinikos

City

Vilnius

ZIP/Postal Code

08410

Country

Lithuania

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11568020

Citation

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.

Results Reference

background

PubMed Identifier

16208620

Citation

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.

Results Reference

background

Links:

URL

http://www.coremedic.ch/about-us/

Description

Sponsor's Website

URL

https://www.meditrialeurope.com/

Description

Collaborator's Website

URL

http://www.santa.lt/

Description

Recruiting Site

Learn more about this trial

ChordArt System for Mitral Regurgitation

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