NCT06414265

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: InnovHeart · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Transcatheter mitral valve replacement	The SATURN TS TMVR System will be implanted through a transcatheter approach in patients with symptomatic mitral regurgitation.

Timeline

• Start date: 2024-04-04
• Primary completion: 2025-03-01
• Completion: 2030-02-01
• First posted: 2024-05-16
• Last updated: 2024-08-23

Locations

3 sites across 3 countries: Georgia, Lithuania, Poland