Clinical trial NCT03581656: ChordArt System for Mitral Regurgitation
Official title: ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Valve Repair
Mitral Regurgitation
Mitral Valve Insufficiency
Keywords: Degenerative Mitral Leaflet Prolapse
Heart Disease
Minimally Invasive
Lead sponsor: CoreMedic GmbH
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2018-07-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: All-cause mortality
timeFrame: At 30 days from implant procedure
measure: Major adverse events
timeFrame: At 30 days from implant procedure
Secondary outcomes:
measure: Technical Success
timeFrame: End of Implantation Procedure
measure: Device Performance
timeFrame: At 30 days
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
Study officials:
affiliation: Heart Surgery Centre, Santariskiu Vilnius
name: Kestutis Rucinskas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.