Mitral valve replacement with the SATURN TMVR system for severe mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 adults at up to five US sites to evaluate the technical feasibility, safety, and performance of the SATURN TS TMVR system for treating moderate-severe to severe mitral regurgitation via a transcatheter approach. The device consists of a self-expanding nitinol frame with bovine leaflets and a dedicated annular structure, delivered through a transcatheter route after physician training. Primary objectives focus on implant feasibility, acute safety, and device performance; secondary objectives assess long-term safety and performance outcomes. Eligible participants are adults with symptomatic high-grade MR, NYHA class II or higher, and high surgical risk who can tolerate anticoagulation and bailout surgery if needed.

Why it matters

Who can join: the full rules

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 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.
* 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.

CABG or PCI within previous 30 days.

* 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:

  1. Patients with ascites.
  2. Patients with anasarca (generalized edema / hydropsy).
* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure with the exception of dilated ischemic or non-ischemic cardiomyopathy.

Procedural Exclusion Criteria

* Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).
* Documented hypersensitivity to nickel or titanium.

Cardiac Imaging Exclusion Criteria (evaluated by Core Labs)

* 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.

Where it's running

• Los Robles Regional Medical Center
  Thousand Oaks, California, United States Recruiting
• Columbia University Irving Medical Center/New York Presbyterian Hospital
  New York, New York, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Not yet recruiting
• UC Davis Health
  Sacramento, California, United States Not yet recruiting
• Oregon Health & Science University
  Portland, Oregon, United States Not yet recruiting

Study contacts

• Study coordinator: Angelic Roach, MSc
• Email: a.roach@innovheart.com
• Phone: +39 0125538873

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.