Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation

Not Applicable

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06414265
• Lead Sponsor: InnovHeart

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-4-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age 65 years or older.<br><br> 2. Symptomatic moderate to severe or severe functional mitral regurgitation (= Grade<br> 3+).<br><br> 3. NYHA functional Class = II. If Class IV, patient must be ambulatory.<br><br> 4. Ability to tolerate oral anticoagulation.<br><br> 5. Ability to qualify for bailout surgery (which may include open heart surgery).<br><br> 6. High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty,<br> as determined by the Heart Team.<br><br> 7. Willing and able to complete study-related assessments and questionnaires.<br><br>Exclusion Criteria:<br><br>General Exclusion Criteria<br><br> 1. Degenerative (i.e. intrinsic valve lesions) mitral regurgitation.<br><br> 2. Excessive frailty or comorbid conditions that preclude the anticipated benefit of<br> the mitral valve replacement.<br><br> 3. Life expectancy <1 year due to noncardiac conditions.<br><br> 4. Endocarditis in the 3 months prior to procedure date.<br><br> 5. Current admission with acute heart failure exacerbation.<br><br> 6. Dependency on inotropic agents or mechanical circulatory support.<br><br> 7. Untreated clinically significant CAD.<br><br> 8. Active systemic infection.<br><br> 9. Modified Rankin Scale =4 disability.<br><br> 10. Chronic renal failure defined as eGFR <30 mL/min/m2 or on renal replacement therapy.<br><br> 11. Severe pulmonary arterial hypertension (PAH), defined as PASP > 60mmHg.<br><br> 12. Platelets < 90,000.<br><br> 13. COPD 2 on home oxygen therapy deemed too high risk for intubation.<br><br> 14. Refuses blood transfusions.<br><br> 15. Documented bleeding or coagulation disorders (hypo- or hyper-coagulable states).<br><br> 16. Severe connective tissue disease under chronic immunosuppressive or cortisone<br> therapy.<br><br> 17. Participating in other investigational studies likely to confound the results or<br> affect the study.<br><br> 18. Unable or does not sign the study informed consent form.<br><br> 19. Patients classified as vulnerable patients 3 .<br><br> Cardiovascular Exclusion Criteria<br><br> 20. Myocardial infarction during prior 30 days.<br><br> 21. Stroke or TIA during prior 90 days.<br><br> 22. Severe extracardiac arteriopathy (safety measure for extra-circulatory support if<br> surgical conversion is needed).<br><br> 23. Prior mitral valve treatment (e.g., valve repair or replacement, MitraClip, etc.),<br> and/or anticipated mitral valve treatment prior to enrollment.<br><br> 24. Prior surgical mechanical valve AVR.<br><br> 25. Prior TAVI.<br><br> 26. Need for any planned cardiovascular surgery or intervention (other than for MV<br> disease) within 30 days post-index procedure.<br><br> 27. CRT or ICD implanted in previous 30 days.<br><br> 28. Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure <90mmHg,<br> Inotropic dependent or requiring IABP/mechanical circulatory support.<br><br> 29. CABG or PCI within previous 30 days.<br><br> 30. Inadequately treated for cardiac condition per applicable standards, such as for<br> coronary artery disease, left ventricular dysfunction, mitral regurgitation, or<br> heart failure, as reviewed by the Patient Screening Committee.<br><br> 31. Prior or planned heart transplantation (UNOS status 1).<br><br> 32. Physical evidence of right-sided congestive heart failure:<br><br> 1. Patients with ascites.<br><br> 2. Patients with anasarca (generalized edema / hydropsy).<br><br> 33. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis,<br> or other structural heart disease causing heart failure with the exception of<br> dilated ischemic or non-ischemic cardiomyopathy.<br><br> Procedural Exclusion Criteria<br><br> 34. Known hypersensitivity or contraindication to procedural or post-procedural<br> medication (e.g., contrast solution, anticoagulation therapy).<br><br> 35. Documented hypersensitivity to nickel or titanium.<br><br> 36. Contraindications to TEE imaging<br><br> Cardiac Imaging Exclusion Criteria<br><br> 37. Left ventricular EF = 30% by echocardiogram.<br><br> 38. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or<br> mass.<br><br> 39. Extensive mitral flail leaflets<br><br> 40. Evidence of new or untreated intracardiac thrombus, mass, or vegetation.<br><br> 41. Severe right ventricular dysfunction.<br><br> 42. Severe tricuspid regurgitation.<br><br> 43. Hemodynamically significant inter-atrial shunt (ASD).<br><br> 44. Severe aortic regurgitation or aortic stenosis.<br><br> 45. Anatomic ineligibility for SATURN TS Bioprosthetic System or SATURN TS procedure as<br> determined by the Screening Committee.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Endpoint - Freedom from Device Related Major Adverse Events;Technical Procedural Success Endpoint;Efficacy Endpoint - Reduction of Mitral Regurgitation Grade to = 1+