Mitral RegurgitationCASSINI-USNCT07130994
Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)
A study testing Mitral Valve Replacement in people with Mitral Regurgitation and Heart Disease, run by InnovHeart at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Heart Disease
- What is being tested?
- Mitral Valve Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Aug 2026to Sep 2032
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- 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.
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
David Wilson contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mitch Gheorghiu, mitch.gheorghiu@chcshs.org
Raj Makkar
- Recruiting
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Treena Williams, taw2112@cumc.columbia.edu
Torsten Vahl
- Not yet recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Amy Koski, koskia@ohsu.edu
Firas Zahr
- Not yet recruiting
UC Davis Health
Sacramento, California, 95817
Kaelyn Tuerner-Lee, ktuernerlee@ucdavis.edu
Gagan Singh
- Recruiting
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Reas Solomon, hereasie.solomon@hcahealthcare.com
Saibal Kar
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-US)
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.
Read the 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.
- Conditions
- Mitral Regurgitation, Heart Disease
- Being tested
- Mitral Valve Replacement
- Keywords
- Transcatheter, Mitral Valve, Replacement
- Medical subject headings
- Mitral Valve Insufficiency, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral Valve ReplacementDevice
Implant of SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation
| Study group | Role | What they receive |
|---|---|---|
| SATURN TMVR Cohort | Experimental | Saturn transseptal TMVR System implant Receives: Device: Mitral Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical (Implant) Success Endpoint
Presented as the n/N (%) of patients that meet the definition of Implant Success per protocol.
Measured: At completion of study procedure (Day 0)
Freedom from Major Adverse Events Endpoint
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.
Measured: 30 days from index procedure
Mitral Valve Effectiveness Endpoint (reduction in MR grade)
Defined as the reduction of mitral regurgitation Grade to ≤1+ at 30 days.
Measured: 30 days post treatment
Secondary outcomes (1)
Mitral Valve Performance over time Endpoint
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
Measured: 5 years post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start5 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnovHeart
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130994
- Sponsor's protocol ID
- TP-0144
- Acronym
- CASSINI-US
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 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-US)
- ClinicalTrials.gov ID
- NCT07130994
- Acronym / sponsor ID
- CASSINI-US / TP-0144
- Conditions
- Mitral Regurgitation, Heart Disease
- Keywords
- Transcatheter, Mitral Valve, Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- InnovHeartIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 19 Aug 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SATURN TMVR Cohort | Experimental | Device: Mitral Valve ReplacementSaturn transseptal TMVR System implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (49 listed)
- 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.
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 |
|---|---|---|
| Mitral Valve ReplacementImplant of SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation | Device | SATURN TMVR Cohort |
Primary outcome
Technical (Implant) Success Endpoint
Time frame: 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
Time frame: 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)
Time frame: 30 days post treatment
Defined as the reduction of mitral regurgitation Grade to ≤1+ at 30 days.
1 secondary outcome
Mitral Valve Performance over time Endpoint
Time frame: 5 years post index procedure
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 10 Aug 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.
David Wilson contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral Valve Replacement in people with Mitral Regurgitation and Heart Disease, run by InnovHeart at 5 sites in United States.
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 49 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 Angelic Roach, MSc (+39 0125538873, a.roach@innovheart.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical (Implant) Success Endpoint (time frame: At completion of study procedure (Day 0)). 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 10 Aug 2026.