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

Heart Failure Clinical Trial

Official title: Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-Septal TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - CASSINI-EU Trial

Status Recruiting

Clinical Trial 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)

Clinical Trial Description

The SATURN Trans-Septal Transcatheter Mitral Valve Replacement System (SATURN TS System) is intended for use in adult patients suffering from heart failure symptoms (NYHA class II or greater) with moderate to severe or severe mitral regurgitation (MR ≥3+) who are deemed to be at high risk for open-heart mitral valve surgery by a multidisciplinary Heart Team including at least a cardiac surgeon and a cardiologist, experienced in the care of patients with mitral valve disease.

CASSINI-EU is a single-arm, prospective, multicenter pilot trial. The purpose of the study 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.

Primary objectives are to evaluate the feasibility, safety and performance of the SATURN TS TMVR System at 30 days. Secondary objectives and additional outcomes are long term safety and performance of the SATURN TS TMVR System.

Up to 30 patients will be treated at up to 6 qualified investigational sites in Europe. ;

Related Conditions & MeSH terms

• Heart Failure
• Mitral Valve Insufficiency

• NCT number: NCT06414265
• Study type: Interventional
• Source: InnovHeart
• Contact: VP, Clinical Affairs InnovHeart
• Phone: +49 69 24003626
• Email: a.roach@innovheart.com
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Completion date: February 2030