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

NCT07130994 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: TP-0144
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Mitral Regurgitation; Heart Disease

Keywords

Transcatheter; Mitral Valve; Replacement

Outcome Measures

Primary Outcomes (3)

• Technical (Implant) Success Endpoint

  Presented as the n/N (%) of patients that meet the definition of Implant Success per protocol.

  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.

  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.

  30 days post treatment

Secondary Outcomes (1)

• Mitral Valve Performance over time Endpoint

  5 years post index procedure

Other Outcomes (4)

• Additional Safety Measurements (Incidence of AEs)

  Measured at 30 days, 1 year and annually thereafter through 5 years post index procedure

• Change in Quality of Life (KCCQ)

  Baseline, 30 days, 3 months, 6 months, 1 year and annually thereafter through 5 years post index procedure

• Change in NYHA Classification

  Baseline, 30 days, 3 months, 6 months, 1 year and annually thereafter through 5 years post index procedure

Study Arms (1)

SATURN TMVR Cohort

EXPERIMENTAL

Device: Mitral Valve Replacement

Interventions

Mitral Valve Replacement DEVICE

Implant of SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation

SATURN TMVR Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• InnovHeart: lead
• Avania: collaborator

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Diseases

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Cardiovascular Diseases

Study Officials

• Torsten P Vahl, MD

  Columbia University, New York, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelic Roach, MSc

CONTACT

+39 0125538873; a.roach@innovheart.com

David Wilson

CONTACT

d.wilson@innovheart.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2032
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share