Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT07130994
Brief Summary:
CASSINI-US is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 patients at up to 5 sites in the United States (US).
The purpose of the study is to evaluate the technical (implant) feasibility, and safety, and performance of the SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation through a transcatheter approach.
Primary objectives evaluate the implant feasibility, and acute safety and performance of the SATURN TS TMVR System. The secondary objective and additional outcome measures characterize the long-term safety and performance of the SATURN TS TMVR System.
Detailed Description:
The SATURN Bioprosthesis is designed to be implanted in the native mitral heart valve without open-heart surgery, extracorporeal circulation, cardiac arrest or removal of the failed native valve. The SATURN Bioprosthesis consists of the annular structure (Annular Segments) and the valve (SATURN Valve).
The valve supports a set of prosthetic leaflets that are the functional elements of the bioprosthesis. The valve is made of a self-expandable Nitinol frame supports three bovine pericardium leaflets. The valve is assembled with the annular structure through two connecting blocks mounted on the connecting arms of the stent.
The SATURN Delivery System and Accessories provides a transcatheter pathway to deliver the SATURN valve through the septum via the femoral vein. The SATURN Delivery System consists of an outer sheath, a guidewire delivery system, a valve delivery system and accessories.
The use of the SATURN TS System is carried out according to precise specifications and indications specified in the Instructions for Use (IFU) and is restricted to those physicians who have undergone dedicated training on use of the device.
Participants will be screened based on predefined inclusion and exclusion criteria. Eligible subjects will provide informed consent prior to any study-related procedures.
The clinical study designed to evaluate the safety, performance, and long-term clinical outcomes in adult patients with cardiac conditions. The study aims to collect comprehensive clinical data across patient population to support the understanding of procedural success, device-related outcomes, and patient recovery over time.
Participants will be followed from screening through five years post-procedure, with scheduled evaluations at the following timepoints: Screening, Baseline (pre-procedure), Intraprocedural, 24-48 hours post-procedure, 7 days or discharge, 1 month (±7 days), 3 months (±14 days), 6 months (±30 days), 1 year (±30 days), and annually through year five (±60 days).
Clinical assessments include physical examination, vital signs, and review of cardiac and antithrombotic medications. Functional status is evaluated using the Modified Rankin Scale, New York Heart Association (NYHA) classification, and the 6-Minute Walk Test. Quality of life is assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Risk stratification is performed at screening using EuroSCORE II and STS Risk Score.
Laboratory testing includes hematology, coagulation profiles, renal and liver function tests , and cardiac biomarkers such as NT-proBNP and plasma-free hemoglobin. Pregnancy testing is conducted at baseline for applicable participants.
Imaging and diagnostic testing includes transthoracic and transesophageal echocardiography (TTE/TEE), cardiac and vascular CT, gated cardiac CT at 6 months, 12-lead ECG, and intraprocedural assessments such as fluoroscopy, angiography, and right heart catheterization.
Safety endpoints include the incidence of adverse events (AEs), device deficiencies or malfunctions, and protocol deviations. The study is designed to generate robust clinical evidence supporting the intervention's safety, efficacy, and durability over time, and to inform future clinical practice and regulatory submissions.
Study:
NCT07130994
Study Brief:
Protocol Section:
NCT07130994