Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovHeart
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Mitral Valve Replacement
DeviceImplant of SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: SATURN TMVR CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Technical (Implant) Success Endpoint
Presented as the n/N (%) of patients that meet the definition of Implant Success per protocol.
Time frame
At completion of study procedure (Day 0)2
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.
Time frame
30 days from index procedure3
Mitral Valve Effectiveness Endpoint (reduction in MR grade)
Defined as the reduction of mitral regurgitation Grade to ≤1+ at 30 days.
Time frame
30 days post treatmentSecondary 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
Time frame
5 years post index procedureOther outcomes
1
Additional Safety Measurements (Incidence of AEs)
* All-cause mortality * All strokes * Acute kidney injury (AKI) * Mitral valve surgery or re-intervention * Re-hospitalizations for heart failure
Time frame
Measured at 30 days, 1 year and annually thereafter through 5 years post index procedure2
Change in Quality of Life (KCCQ)
The subject reported quality-of-life score (KCCQ) will be reported at each visit and compared to baseline. Scale 0-100, higher scores mean better outcomes.
Time frame
Baseline, 30 days, 3 months, 6 months, 1 year and annually thereafter through 5 years post index procedure3
Change in NYHA Classification
The physician reported NYHA assessment (I-IV) will be reported at each visit and compared to baseline. Scale I-IV, higher score means a worse outcome.
Time frame
Baseline, 30 days, 3 months, 6 months, 1 year and annually thereafter through 5 years post index procedure4
Change in Six Minute Walk Test (6MWT)
The distance walked (m) during the 6MWT will be reported at each visit and compared to baseline.
Time frame
Baseline, 30 days, 3 months, 6 months, 1 year and annually thereafter through 5 years post index procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
InnovHeart
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov