MedTrace Logo

SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

NCT04464876 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-22

No results posted yet for this study

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

Interventions

DEVICE

SATURN TA System

SATURN TA TMVR Device implanted

Sponsors & Collaborators

  • InnovHeart

    lead INDUSTRY

Principal Investigators

  • Marie Steinbrink · InnovHeart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2022-09-30
Completion
2024-12-31

Countries

  • Denmark
  • Hungary
  • Lithuania

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04464876 on ClinicalTrials.gov