Mitral Regurgitation, Mitral Valve Insufficiency, Mitral Valve Repair
Conditions
Keywords
Degenerative Mitral Leaflet Prolapse, Heart Disease, Minimally Invasive
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.
Interventions
DEVICEChordArt 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.
Sponsors
Meditrial Europe Ltd.
CoreMedic GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | At 30 days from implant procedure | The frequency of all-cause mortality |
| Major adverse events | At 30 days from implant procedure | The frequency of pre-determined major adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Device Performance | At 30 days | The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography. |
Countries
Lithuania
Outcome results
None listed