SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

Not Applicable

Active, not recruiting

• Conditions: Mitral Regurgitation; Valve Heart Disease; Mitral Valve Disease; Mitral Disease; Heart Valve Diseases
• Interventions: Device: SATURN TA System

• Registration Number: NCT04464876
• Lead Sponsor: InnovHeart

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Study Start: 2020-08-19
• Primary Completion: 2022-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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).

10. Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.

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

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

13. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	SATURN TA System	SATURN TA TMVR Device implanted

Primary Outcome Measures

Name	Time	Method
Reduction of mitral regurgitation	30 days	Reduction of mitral regurgitation to ≤1 at 30 days.
Freedom from device-related or procedure-related major adverse events	30 days	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).
Technical success	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Freedom from device-related or procedure-related major adverse events	30 days, 1 year, 2 years	* Freedom from device-related or procedure-related major adverse events throughout long- term follow-up.; * Freedom from all-cause mortality
NYHA functional classification	30 days, 1 year, 2 years	Improvement from baseline by ≥ 1 functional classification.
Patients success	30 days, 1 year, 2 years	Patients success
KCCQ	30 days, 1 year, 2 years	Improvement from baseline in Quality of Life by ≥ 10 points.
Freedom from all-cause mortality	30 days, 1 year, 2 years	Freedom from all-cause mortality
Device success	30 days, 1 year, 2 years	Device success
6 Minute Hall Walk Test	30 days, 1 year, 2 years	Improvement from baseline in functional status by ≥ 30 meters

Trial Locations

Locations (3)

Heart And Vascular Center, Semmelweis University; 🇭🇺 Budapest, Hungary

Vilnius University Hospital Santaros klinikos; 🇱🇹 Vilnius, Lithuania

Rigshospitalet University Hospital of Copenhagen; 🇩🇰 Copenhagen, Denmark