Heart FailureCASSINI-EUNCT06414265
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
A study testing Transcatheter mitral valve replacement in people with Heart Failure, run by InnovHeart at 8 sites in 5 countries.
Trial summary
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Transcatheter mitral valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 4 Apr 2024to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older.
- Symptomatic moderate to severe or severe functional 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.
Who cannot join
- General Exclusion Criteria
- Degenerative (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 year due to noncardiac conditions.
- Endocarditis in the 3 months prior to procedure date.
- Current admission with acute heart failure exacerbation.
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- 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 > 60mmHg.
- Platelets < 90,000.
- COPD 2 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" 3 .
- 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 or ICD implanted in previous 30 days.
- Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure <90mmHg, Inotropic dependent or requiring 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 congestive heart failure:
- Patients with ascites.
- 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.
- Contraindications to TEE imaging
- Cardiac Imaging Exclusion Criteria
- 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 TS Bioprosthetic System or SATURN TS procedure as determined by the Screening Committee.
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Maxis Operations contact
8 sites in 5 countries
Georgia2 sites, 2 recruiting
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi
- Recruiting
Tbilisi Heart Center
Tbilisi
Archil Chukhrukidze
Italy2 sites, 2 recruiting
- Recruiting
Ospedale San Raffaele
Milan, 20132
Paolo Denti
- Recruiting
Instituto Clinico Humanitas
Milan
Antonio Mangieri
Poland2 sites, 2 recruiting
- Recruiting
Górnośląskie Centrum Medyczne
Katowice
Wojciech Wajakowski
- Recruiting
Warsaw Medical University
Warsaw
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Sussex County Hospital
Brighton
David Hildick-Smith
About this study
Official title: Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-Septal TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - CASSINI-EU Trial
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are:
- is the use of the device feasible?
- is it safe (defined as freedom from device-related major adverse events at 30 days)?
- does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)?
Read more
Participants will need to do the following as part of the clinical trial:
- complete 6-Minute Walking Test
- complete Quality of Life Questionnaires
- undergo blood evaluations
- CT scan
- 12 lead ECG
- Transesophageal Echocardiography
- Transthoracic Echocardiogram
- the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram)
Read the detailed description
The SATURN Trans-Septal Transcatheter Mitral Valve Replacement System (SATURN TS System) is intended for use in adult patients suffering from heart failure symptoms (NYHA class II or greater) with moderate to severe or severe mitral regurgitation (MR ≥3+) who are deemed to be at high risk for open-heart mitral valve surgery by a multidisciplinary Heart Team including at least a cardiac surgeon and a cardiologist, experienced in the care of patients with mitral valve disease.
CASSINI-EU is a single-arm, prospective, multicenter pilot trial. The purpose of the study is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach.
Primary objectives are to evaluate the feasibility, safety and performance of the SATURN TS TMVR System at 30 days. Secondary objectives and additional outcomes are long term safety and performance of the SATURN TS TMVR System.
Up to 30 patients will be treated at up to 6 qualified investigational sites in Europe.
- Conditions
- Heart Failure
- Being tested
- Transcatheter mitral valve replacement
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter mitral valve replacementDevice
The SATURN TS TMVR System will be implanted through a transcatheter approach in patients with symptomatic mitral regurgitation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | SATURN Trans-septal Transcatheter mitral valve replacement (TMVR) System Receives: Device: Transcatheter mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint - Freedom from Device Related Major Adverse Events
Freedom from device-related major adverse events
Measured: 30 days post-procedure
Technical Procedural Success Endpoint
Technical success defined as alive patient at exit from procedure room with all the following:
- Successful access, delivery of the SATURN TS Bioprosthesis, and retrieval of the TS Delivery Systems
- Correct positioning of the first intended SATURN TS Bioprosthesis
- Freedom from emergency surgery or mitral valve re-intervention related to the device or access procedure
Measured: Procedure
Efficacy Endpoint - Reduction of Mitral Regurgitation Grade to ≤ 1+
Reduction of MR Grade to ≤ 1+
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start4 Apr 2024
- Primary completionMar 2027 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnovHeart
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Paolo Denti, MD, Principal investigator, San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414265
- Sponsor's protocol ID
- TP-0181
- Acronym
- CASSINI-EU
- Status last verified
- May 2026
- First submitted
- 29 Apr 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-Septal TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - CASSINI-EU Trial
- ClinicalTrials.gov ID
- NCT06414265
- Acronym / sponsor ID
- CASSINI-EU / TP-0181
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- InnovHeartIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are:
- is the use of the device feasible?
- is it safe (defined as freedom from device-related major adverse events at 30 days)?
- does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)?
Participants will need to do the following as part of the clinical trial:
- complete 6-Minute Walking Test
- complete Quality of Life Questionnaires
- undergo blood evaluations
- CT scan
- 12 lead ECG
- Transesophageal Echocardiography
- Transthoracic Echocardiogram
- the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram)
Detailed description
The SATURN Trans-Septal Transcatheter Mitral Valve Replacement System (SATURN TS System) is intended for use in adult patients suffering from heart failure symptoms (NYHA class II or greater) with moderate to severe or severe mitral regurgitation (MR ≥3+) who are deemed to be at high risk for open-heart mitral valve surgery by a multidisciplinary Heart Team including at least a cardiac surgeon and a cardiologist, experienced in the care of patients with mitral valve disease.
CASSINI-EU is a single-arm, prospective, multicenter pilot trial. The purpose of the study is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach.
Primary objectives are to evaluate the feasibility, safety and performance of the SATURN TS TMVR System at 30 days. Secondary objectives and additional outcomes are long term safety and performance of the SATURN TS TMVR System.
Up to 30 patients will be treated at up to 6 qualified investigational sites in Europe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Transcatheter mitral valve replacementSATURN Trans-septal Transcatheter mitral valve replacement (TMVR) System |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 years or older.
- Symptomatic moderate to severe or severe functional 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).
Key exclusion criteria (51 listed)
- General Exclusion Criteria
- Degenerative (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 year due to noncardiac conditions.
- Endocarditis in the 3 months prior to procedure date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter mitral valve replacementThe SATURN TS TMVR System will be implanted through a transcatheter approach in patients with symptomatic mitral regurgitation. | Device | Treatment Arm |
Primary outcome
Safety Endpoint - Freedom from Device Related Major Adverse Events
Time frame: 30 days post-procedure
Freedom from device-related major adverse events
Technical Procedural Success Endpoint
Time frame: Procedure
Technical success defined as alive patient at exit from procedure room with all the following: * Successful access, delivery of the SATURN TS Bioprosthesis, and retrieval of the TS Delivery Systems * Correct positioning of the first intended SATURN TS Bioprosthesis * Freedom from emergency surgery or mitral valve re-intervention related to the device or access procedure
Efficacy Endpoint - Reduction of Mitral Regurgitation Grade to ≤ 1+
Time frame: 30 days post-procedure
Reduction of MR Grade to ≤ 1+
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maxis Operations contact
Paolo Denti, MD principal investigator
San Raffaele Hospital
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter mitral valve replacement in people with Heart Failure, run by InnovHeart at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Georgia, Italy, Poland, Lithuania, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VP, Clinical Affairs InnovHeart (+49 69 24003626, a.roach@innovheart.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint - Freedom from Device Related Major Adverse Events (time frame: 30 days post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.