SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Valve Diseases; Mitral Regurgitation; Valve Heart Disease; Mitral Valve Disease; Mitral Disease
• Intervention / Treatment: Device: SATURN TA System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet University Hospital of Copenhagen
• Hungary
  • Budapest, Hungary
    • Heart And Vascular Center, Semmelweis University
• Lithuania
  • Vilnius, Lithuania
    • Vilnius University Hospital Santaros Klinikos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; SATURN TA TMVR Device implanted	Device: SATURN TA System; SATURN TA TMVR Device implanted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Reduction of mitral regurgitation	Reduction of mitral regurgitation to ≤1 at 30 days.	30 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Freedom from all-cause mortality	Freedom from all-cause mortality	30 days, 1 year, 2 years
Patients success	Patients success	30 days, 1 year, 2 years
Device success	Device success	30 days, 1 year, 2 years
6 Minute Hall Walk Test	Improvement from baseline in functional status by ≥ 30 meters	30 days, 1 year, 2 years
KCCQ	Improvement from baseline in Quality of Life by ≥ 10 points.	30 days, 1 year, 2 years
NYHA functional classification	Improvement from baseline by ≥ 1 functional classification.	30 days, 1 year, 2 years

Collaborators and Investigators

• Sponsor: InnovHeart
• Investigators: Study Director: Marie Steinbrink, InnovHeart

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Mitral Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: TP-0050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No