Clinical trial NCT04464876: SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
Official title: SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Valve Heart Disease
Heart Valve Diseases
Mitral Valve Disease
Mitral Disease
Lead sponsor: InnovHeart
Sponsor class: INDUSTRY
First posted: 2020-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from device-related or procedure-related major adverse events
timeFrame: 30 days
measure: Reduction of mitral regurgitation
timeFrame: 30 days
measure: Technical success
timeFrame: Day 0
Secondary outcomes:
measure: Freedom from device-related or procedure-related major adverse events
timeFrame: 30 days, 1 year, 2 years
measure: Freedom from all-cause mortality
timeFrame: 30 days, 1 year, 2 years
measure: Patients success
timeFrame: 30 days, 1 year, 2 years
measure: Device success
timeFrame: 30 days, 1 year, 2 years
measure: 6 Minute Hall Walk Test
timeFrame: 30 days, 1 year, 2 years
measure: KCCQ
timeFrame: 30 days, 1 year, 2 years
measure: NYHA functional classification
timeFrame: 30 days, 1 year, 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet University Hospital of Copenhagen
city: Budapest
country: Hungary
facility: Heart And Vascular Center, Semmelweis University
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros klinikos
Study officials:
affiliation: InnovHeart
name: Marie Steinbrink
role: STUDY_DIRECTOR
References: