SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

NCT04464876 | Unknown DMC

• 1 other identifier: TP-0050
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 3

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.

Conditions

Mitral Regurgitation; Valve Heart Disease; Heart Valve Diseases; Mitral Valve Disease; Mitral Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Freedom from device-related or procedure-related major adverse events

  30 days, 1 year, 2 years

• Freedom from all-cause mortality

  30 days, 1 year, 2 years

• Patients success

  30 days, 1 year, 2 years

• Device success

  30 days, 1 year, 2 years

• 6 Minute Hall Walk Test

  30 days, 1 year, 2 years

Study Arms (1)

Treatment

EXPERIMENTAL

SATURN TA TMVR Device implanted

Device: SATURN TA System

Interventions

SATURN TA System DEVICE

SATURN TA TMVR Device implanted

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Severe functional mitral regurgitation (≥ Grade 3+).
• NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
• Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for heart failure for at least 30 days.
• Not a suitable candidate for open mitral valve surgery due to high operative risk, as determined by the Heart Team.
• Able to complete quality-of-life assessment (KCCQ).

You may not qualify if:

• Excessive frailty or comorbid conditions that preclude the anticipated benefit of the valve replacement.
• Life expectancy \<1 yr due to noncardiac conditions.
• Active endocarditis.
• Active systemic infection.
• Modified Rankin Scale ≥4 disability.
• Hemodialysis/ chronic renal failure (eGFR \< 35 mL/min/m2).
• Pulmonary arterial hypertension (fixed PAS \< 60mmHg). 8) COPD on home oxygen.
• \) Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo- or hyper-coagulable states).
• \) Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.
• \) Pregnant/ lactating. Females of childbearing age must be willing to take contraceptives.
• \) Participating in other investigational studies likely to confound the results or affect the study.
• \) Unable to consent. 15) Unable or unwilling to comply with study Follow-up. 16) Patients classified as "vulnerable patients".
• Myocardial infarction during prior 30 days.
• Stroke or TIA during prior 30 days.
• Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).

Sponsors & Collaborators

• InnovHeart: lead

Study Sites (3)

Rigshospitalet University Hospital of Copenhagen

Copenhagen, Denmark

Location

Heart And Vascular Center, Semmelweis University

Budapest, Hungary

Location

Vilnius University Hospital Santaros klinikos

Vilnius, Lithuania

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Valve Diseases; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Steinbrink

  InnovHeart

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 9, 2020
• Study Start: August 19, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); LI (1); DK (1)