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| ID | Type | Description | Link |
|---|---|---|---|
| CHAGALL | Other Identifier | Other Identifier |
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| Name | Class |
|---|---|
| Meditrial Europe Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChordArt System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | The frequency of all-cause mortality | At 30 days from implant procedure |
| Major adverse events | The frequency of pre-determined major adverse events | At 30 days from implant procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of Implantation Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kestutis Rucinskas, MD | Heart Surgery Centre, Santariskiu Vilnius | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vilnius University Hospital Santariskiu Klinikos | Vilnius | 08410 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11568020 | Background | 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. | |
| 16208620 | Background | 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. |
| Label | URL |
|---|---|
| Sponsor's Website | View source |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| Device Performance | The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography. | At 30 days |
| Collaborator's Website | View source |