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Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation

NCT06414265 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-20

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are:

* is the use of the device feasible?
* is it safe (defined as freedom from device-related major adverse events at 30 days)?
* does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)?

Participants will need to do the following as part of the clinical trial:

* complete 6-Minute Walking Test
* complete Quality of Life Questionnaires
* undergo blood evaluations
* CT scan
* 12 lead ECG
* Transesophageal Echocardiography
* Transthoracic Echocardiogram
* the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram)

Conditions

Interventions

DEVICE

Transcatheter mitral valve replacement

The SATURN TS TMVR System will be implanted through a transcatheter approach in patients with symptomatic mitral regurgitation.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • InnovHeart

    lead INDUSTRY

Principal Investigators

  • Paolo Denti, MD · San Raffaele Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2027-03-31
Completion
2030-02-28

Countries

  • Georgia
  • Italy
  • Lithuania
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT06414265 on ClinicalTrials.gov