SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

Mitral Regurgitation Clinical Trial

Official title:

SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04464876
• Other study ID #: TP-0050
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: InnovHeart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical treatment following Heart Team assessment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older.

2. Severe functional mitral regurgitation (= Grade 3+).

3. NYHA functional Class = II. If Class IV, patient must be ambulatory.

4. Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for heart failure for at least 30 days.

5. Not a suitable candidate for open mitral valve surgery due to high operative risk, as determined by the Heart Team.

6. Able to complete quality-of-life assessment (KCCQ).

General Exclusion Criteria:

1. Excessive frailty or comorbid conditions that preclude the anticipated benefit of the valve replacement.

2. Life expectancy <1 yr due to noncardiac conditions.

3. Active endocarditis.

4. Active systemic infection.

5. Modified Rankin Scale =4 disability.

6. Hemodialysis/ chronic renal failure (eGFR < 35 mL/min/m2).

7. Pulmonary arterial hypertension (fixed PAS < 60mmHg). 8) COPD on home oxygen.

9) Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo- or hyper-coagulable states).

11) Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.

12) Pregnant/ lactating. Females of childbearing age must be willing to take contraceptives.

13) Participating in other investigational studies likely to confound the results or affect the study.

14) Unable to consent. 15) Unable or unwilling to comply with study Follow-up. 16) Patients classified as "vulnerable patients".

Cardiovascular Exclusion Criteria:

1. Myocardial infarction during prior 30 days.

2. Stroke or TIA during prior 30 days.

3. Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).

4. Prior mitral valve treatment (e.g. valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment.

5. Prior surgical mechanical valve AVR.

6. Prior TAVI.

7. Need for any cardiovascular surgery or intervention (other than for MV disease) within 30 days.

8. CRT or ICD implanted in previous 30 days.

9. Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure <90mmHg, Inotropic dependent or IABP/mechanical circulatory support.

10. CABG or PCI within previous 30 days.

11. Adequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure. No need for revascularization.

12. Prior or planned heart transplantation (UNOS status 1).

13. Physical evidence of right-sided congestive heart failure:

1. Patients with ascites.

2. Patients with anasarca (generalized edema / hydropsy).

Procedural Exclusion Criteria:

14. Chest condition that prevents transapical access.

15. Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).

16. Documented hypersensitivity to nickel or titanium.

Cardiac Exclusion Criteria (evaluated by Core Labs):

1. Left ventricular EF = 30% by imaging.

2. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.

3. Extensive mitral flail leaflets.

4. Left ventricular thrombus, mass, or vegetation.

5. Left ventricular end-diastolic diameter > 7.5 cm.

6. Severe right ventricular dysfunction.

7. Significant intracardiac shunt.

8. Anatomic ineligibility for SATURN valve as determined by the Screening Committee.

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Mitral Disease
• Mitral Regurgitation
• Mitral Valve Disease
• Mitral Valve Insufficiency
• Valve Heart Disease

Intervention

Device:
• SATURN TA System
SATURN TA TMVR Device implanted

Locations

Country	Name	City	State
Denmark	Rigshospitalet University Hospital of Copenhagen	Copenhagen
Hungary	Heart And Vascular Center, Semmelweis University	Budapest
Lithuania	Vilnius University Hospital Santaros klinikos	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
InnovHeart

Countries where clinical trial is conducted

Denmark,  Hungary,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device-related or procedure-related major adverse events	Freedom from device-related or procedure-related major adverse events at 30 days (cardiac death, peri-procedural myocardial infarction, disabling stroke, renal failure requiring dialysis, life threatening bleeding).	30 days
Primary	Reduction of mitral regurgitation	Reduction of mitral regurgitation to =1 at 30 days.	30 days
Primary	Technical success	Technical success defined as alive patient at exit from procedure room, with all of the following: Successful access, delivery and retrieval of the delivery systems.; Development and correct positioning of the bioprosthesis.; Freedom of additional emergency surgery or re-intervention related to the device or access procedure.	Day 0
Secondary	Freedom from device-related or procedure-related major adverse events	Freedom from device-related or procedure-related major adverse events throughout long- term follow-up.; Freedom from all-cause mortality	30 days, 1 year, 2 years
Secondary	Freedom from all-cause mortality	Freedom from all-cause mortality	30 days, 1 year, 2 years
Secondary	Patients success	Patients success	30 days, 1 year, 2 years
Secondary	Device success	Device success	30 days, 1 year, 2 years
Secondary	6 Minute Hall Walk Test	Improvement from baseline in functional status by = 30 meters	30 days, 1 year, 2 years
Secondary	KCCQ	Improvement from baseline in Quality of Life by = 10 points.	30 days, 1 year, 2 years
Secondary	NYHA functional classification	Improvement from baseline by = 1 functional classification.	30 days, 1 year, 2 years