Mitral Regurgitation Clinical Trial
— CHAGALLOfficial title:
ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail
Verified date | July 2022 |
Source | CoreMedic GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 5 |
Est. completion date | December 2023 |
Est. primary completion date | September 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Lithuania | Vilnius University Hospital Santariskiu Klinikos | Vilnius |
Lead Sponsor | Collaborator |
---|---|
CoreMedic GmbH | Meditrial Europe Ltd. |
Lithuania,
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. — View Citation
Urbanski PP. Modified technique of chordal replacement for mitral valve repair. Thorac Cardiovasc Surg. 2005 Oct;53(5):315-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality | The frequency of all-cause mortality | At 30 days from implant procedure | |
Primary | Major adverse events | The frequency of pre-determined major adverse events | At 30 days from implant procedure | |
Secondary | 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 | |
Secondary | Device Performance | The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography. | At 30 days |
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