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

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation, Heart Disease

In brief

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.

Key facts

Study ID

NCT07130994

Run by

InnovHeart

People needed

15

Starts

2026-08-05

Expected to finish

2032-09-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 Exclusion Criteria
• 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.

Where it is running

• Los Robles Regional Medical Center — Thousand Oaks, California, United States (enrolling)
• Columbia University Irving Medical Center/New York Presbyterian Hospital — New York, New York, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UC Davis Health — Sacramento, California, United States
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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