CHAGALL: ChordArt System for Mitral Regurgitation

• Sponsor: CoreMedic GmbH (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03581656
• Collaborator: Meditrial Europe Ltd. (Industry)
• Enrollment: 5
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 68.4
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Repair; Mitral Regurgitation; Mitral Valve Insufficiency	Device: ChordArt System	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail
• Actual Study Start Date: Mar 21, 2018
• Anticipated Primary Completion Date: Sep 10, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. All-cause mortality [At 30 days from implant procedure]

   The frequency of all-cause mortality

2. Major adverse events [At 30 days from implant procedure]

   The frequency of pre-determined major adverse events

Secondary Outcome Measures

1. Technical Success [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.

2. Device Performance [At 30 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vilnius University Hospital Santariskiu Klinikos	Vilnius		Lithuania	08410

Sponsors and Collaborators

• CoreMedic GmbH
• Meditrial Europe Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor's Website
• Collaborator's Website
• Recruiting Site

Publications

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

• Responsible Party: CoreMedic GmbH
• ClinicalTrials.gov Identifier: NCT03581656
• Other Study ID Numbers: PR-000274-001; CHAGALL
• First Posted: Jul 10, 2018
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CoreMedic GmbH: Degenerative Mitral Leaflet Prolapse; Heart Disease; Minimally Invasive
• Additional relevant MeSH terms: Mitral Valve Insufficiency

Study Results

No Results Posted as of Jul 12, 2022