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CASSINI-US Study for Mitral Regurgitation with SATURN TMVR System

This study, called CASSINI-US, is testing a new device called the SATURN TMVR System for people with moderate-to-severe or severe mitral regurgitation (a heart condition where the mitral valve doesn't close properly, causing blood to leak backward). The SATURN system is designed to replace your mitral valve without open-heart surgery. To join, you must be 18 or older, have symptomatic mitral regurgitation, and be able to take blood thinners. The study aims to see if the SATURN system can be successfully implanted, is safe, and effectively reduces the leakage in your mitral valve. This study is currently enrolling up to 15 patients across the United States.

Study design
This is an early study involving up to 15 patients at several locations in the US. It is a single-arm study, meaning all participants will receive the SATURN TMVR System.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will check for major adverse events and mitral valve effectiveness 30 days after the procedure. Long-term safety and performance will also be evaluated.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07130994

Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)

Recruiting
NAAges 18+InterventionalTreatment
InnovHeart
~15 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Mitral Valve Replacement

At a glance

Recruiting sites
2 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Technical (Implant) Success Endpoint
Measured over At completion of study procedure (Day 0)
+2 more outcomes measured

Conditions

Mitral Regurgitation
Heart Disease

Explore related trials

Mitral Valve Insufficiency

Where it's being run

5 sites across 3 states
California3
New York1
Oregon1

Who to contact

Angelic Roach, MSc
[email protected]
+39 0125538873
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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"
Myocardial infarction during prior 30 days.
Stroke or TIA during prior 90 days.
Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).
Prior mitral valve treatment (e.g., valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment.
Prior surgical mechanical valve AVR.
Prior TAVI. -Need for any planned cardiovascular surgery or intervention (other than for MV disease) within 30 days post-index procedure.
CRT, CRT-D, IPG or ICD implanted in previous 30 days.
Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure \<90mmHg, Inotropic dependent or IABP/mechanical circulatory support.
Inadequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure, as reviewed by the Patient Screening Committee.
Prior or planned heart transplantation (UNOS status 1).
Physical evidence of right-sided CHF:
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure with the exception of dilated ischemic or non-ischemic cardiomyopathy.
Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).
Documented hypersensitivity to nickel or titanium.
Contraindications to TEE imaging
Left ventricular EF ≤ 30% by echocardiogram.
Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
Extensive mitral flail leaflets
Evidence of new or untreated intracardiac thrombus, mass, or vegetation.
Severe right ventricular dysfunction.
Severe tricuspid regurgitation.
Hemodynamically significant inter-atrial shunt (ASD).
Severe aortic regurgitation or aortic stenosis.
Anatomic ineligibility for SATURN Valve or SATURN TS procedure as determined by the Screening Committee.

What this trial measures

  • Technical (Implant) Success EndpointAt 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 Endpoint30 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.