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SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

NCT04464876•InnovHeart

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

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.
+28 more criteria

Locations (3)

Rigshospitalet University Hospital of Copenhagen

Copenhagen, Denmark

Heart And Vascular Center, Semmelweis University

Budapest, Hungary

Vilnius University Hospital Santaros klinikos

Vilnius, Lithuania

Key Dates

Start Date

August 19, 2020

Primary Completion Date

September 30, 2022

Completion Date

December 1, 2024

Last Updated

May 22, 2024

Enrollment

ESTIMATED participants

Conditions

Mitral RegurgitationValve Heart DiseaseHeart Valve DiseasesMitral Valve DiseaseMitral Disease

Interventions

SATURN TA System

DEVICE

A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

NCT07450911

Mitral Regurgitation

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RECRUITING

London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound

NCT05208567

Heart Valve DiseasesLeft Ventricular Dysfunction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

Inclusion Criteria

Exclusion Criteria

A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease