I34.0
Conditions
Interventions
Group 1: Angiographic, catheter based interventional treatment of functional mitral regurgitation by causing collagen contraction in the posterior mitral valve annulus by means of ultrasonic heat app
Sponsors
ReCor Medical, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female and male patients 18 years of age or older 2. Patients with Functional Mitral Valve Insufficiency or regurgitation greater than or equal to 2 to 4+ on a scale of 4+ 3. Long Axis of Mitral Valve is < 4.5 cm by TTE 4. Severe co-morbidities which reveal a predicted risk of operative mortality of 15% and a minimum STS risk calculator score of 8% 5. Negative pregnancy test for female patients of childbearing potential 6. Available for follow-up for at least twelve (12) months. 7. Willing and able to provide signed, informed consent and willing and able to comply with follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Severe calcification of annulus or leaflets in which calcification is visible under fluoroscopy. 2. Mitral Stenosis 3. Mitral valve prolapse (moderate to severe). 4. History of mitral endocarditis. 5. Ruptured chordae tendinae or papillary muscle. 6. Long Axis of Mitral Valve is greater than or equal to 4.5 cm by TTE 7. Previous interventional or surgical treatment for MV Disease. 8. Subjects with ischemia requiring cardiac revascularization (percutaneous or surgical within 3 months prior to or planned after PMVR procedure. 9. An implanted coronary Stent in the Left Circumflex Artery or in close proximity to the mitral annulus. 10. Previous or required repair or replacement of any other non-mitral cardiac valve 11. Unstable Angina defined by one of the following criteria within the last 30 days: Angina that occurred at rest and was prolonged, usually lasting more than 20 minutes, New-onset angina of at least Canadian Cardiovascular Society (CCS) class III severity, and/or Recent acceleration of angina reflected by an increase in severity of at least 1 CCS class to at least CCS class III Positive CK-MB. 12. Acute MI within the last 30 days. 13. Congestive Heart failure with NYHA IV. 14. LV end-diastolic thickness of septal and posterior walls as measured in the parasternal long-axis view to be greater than 1.5 cm. 15. Current or history of left atrial thrombus (even if treated) 16. Ejection fraction less than 25% 17. History of stroke or transient ischemic attack within the last 3 months 18. Previous difficulty in obtaining vascular or transseptal access 19. Known untreated coagulopathy 20. Known life threatening, non-cardiac disease that will limit the subject's life expectancy to less than one year 21. Creatinine greater than 2.0 mg/dl or equivalent units. 22. Allergy to Contrast Media 23. Known alcohol or drug abuser. 24. Currently participating in the study of an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acute Primary Safety Endpoint: Freedom from death, stroke, myocardial infarction (MI), worsening mitral regurgitation, AV block, any malignant rhythm disturbance and cardiac tamponade/ pericardial effusion within 7 days post-procedure. 2. Acute Primary Performance Endpoint: Procedural success as defined by the ability to successfully deploy the PMVR catheter, treat the mitral annulus according to protocol, and demonstrate an acute reduction in mitral annular dimensions (TEE, optional MRI). 3. Acute Secondary Performance Endpoint Hemodynamic performance will be analyzed pre-procedurally and post-procedurally. Summary statistics will be provided for Mitral regurgitation Left ventricular ejection fraction Mitral valve annulus dimensions Left ventricular volume Effective regurgitant orifice area (EROA). Proximal Isovelocity Surface Area (PISA) All data will be captured on CRFs. In addition the patients needs to complete a questionaire of life and a walk test at baseline and at the 1, 3, 6 and 12 month follow-up intervalls | — |
Countries
Germany
Contacts
Public ContactMano Iyer
ReCor Medical, Inc.
Outcome results
None listed