Heart Disease, Mitral Regurgitation
Conditions
Keywords
Transcatheter, Mitral Valve, Replacement
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.
Interventions
DEVICEMitral Valve Replacement
Implant of SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation
Sponsors
InnovHeart
Avania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (Open Label)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Symptomatic, moderate to severe or severe, functional or mixed, mitral regurgitation (≥ Grade 3+). * NYHA functional Class ≥ II. If Class IV, patient must be ambulatory. * Ability to tolerate oral anticoagulation. * Ability to qualify for bailout surgery (which may include open heart surgery). * High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team. * Willing and able to complete study-related assessments and questionnaires.
Exclusion criteria
* Purely degenerative (organic/primary) (i.e. intrinsic valve lesions) mitral regurgitation. * Excessive frailty or comorbid conditions that preclude the anticipated benefit of the mitral valve replacement. * Life expectancy \<1 yr. due to noncardiac conditions. * Endocarditis in the 3 months prior to procedure date. * Current admission with acute heart failure exacerbation. * Dependency on inotropic agents or mechanical circulatory support. * Untreated clinically significant CAD. * Active systemic infection. * Modified Rankin Scale ≥4 disability. * Chronic renal failure defined as eGFR \< 30 mL/min/m2 or on renal replacement therapy. * Severe pulmonary arterial hypertension (PAH), defined as PASP \> 70mmHg. * Platelets \< 90,000. * COPD on home oxygen therapy deemed too high risk for intubation. * Refuses blood transfusions. * Documented bleeding or coagulation disorders (hypo- or hyper-coagulable states). * Severe connective tissue disease under chronic immunosuppressive or cortisone therapy. * Participating in other investigational studies likely to confound the results or affect the study. * Unable or does not sign the study informed consent form. * Patients classified as "vulnerable patients" Cardiovascular
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical (Implant) Success Endpoint | At completion of study procedure (Day 0) | Presented as the n/N (%) of patients that meet the definition of Implant Success per protocol. |
| Freedom from Major Adverse Events Endpoint | 30 days from index procedure | Freedom from (n/N, %) device-related or procedure-related major adverse events (MAE) which include: Cardiovascular death, Peri-procedural myocardial infarction, Disabling stroke, Major cardiac structural complication, Major vascular complication, and Mitral reintervention (operative or transcatheter) due to progressive or recurrent MR or device-related complications. |
| Mitral Valve Effectiveness Endpoint (reduction in MR grade) | 30 days post treatment | Defined as the reduction of mitral regurgitation Grade to ≤1+ at 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mitral Valve Performance over time Endpoint | 5 years post index procedure | Includes the following outcome measured at 30 days, 1 year and annually thereafter through 5 years post index procedure; -Reduction of MR grade compared to baseline and freedom from associated hemolysis |
Countries
United States
Contacts
CONTACTAngelic Roach, MSc
CONTACTDavid Wilson
Outcome results
None listed