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

Part of paid clinical trials in Los Angeles, California.

Sponsor
InnovHeart
Study ID
NCT07130994
Status
Recruiting
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Conditions

  • Heart Disease
  • Mitral Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mitral Valve Replacement — DEVICE
    Implant of SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation

Study Details

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 Dates

First listed
Aug 19, 2025
Start date
Aug 5, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2032

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SATURN TMVR Cohort
    Saturn transseptal TMVR System implant

Primary Outcome Measure

Technical (Implant) Success Endpoint [ Time Frame: At completion of study procedure (Day 0) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Mitch Gheorghiu
[email protected]
Raj Makkar (PRINCIPAL_INVESTIGATOR)
UC Davis HealthSacramentoCalifornia95817
Kaelyn Tuerner-Lee
[email protected]
Gagan Singh (PRINCIPAL_INVESTIGATOR)
Los Robles Regional Medical CenterThousand OaksCalifornia91360
Reas Solomon
[email protected]
Saibal Kar (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical Center/New York Presbyterian HospitalNew YorkNew York10032
Treena Williams
[email protected]
Torsten Vahl (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Firas Zahr (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUC Davis Health· Sacramento, CALos Robles Regional Medical Center· Thousand Oaks, CAColumbia University Irving Medical Center/New York Presbyterian Hospital· New York, NYOregon Health & Science University· Portland, OR

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