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NCT06414265Recruiting

Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation

Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-Septal TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - CASSINI-EU Trial
InnovHeartClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Heart Failure
Drug/Device/Intervention
Transcatheter mitral valve replacement
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
InnovHeart
Location
Vilnius,Warsaw, Lithuania,Poland
Timeline & enrollment
Phase
N/A
Start date
Apr 04, 2024
End date
Feb 01, 2030
Enrollment
30 participants
Primary outcome

Safety Endpoint - Freedom from Device Related Major Adverse Events,Technical Procedural Success Endpoint,Efficacy Endpoint - Reduction of Mitral Regurgitation Grade to ≤ 1+

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. 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)

ICD-10 classifications
Heart failureHeart failure, unspecifiedCongestive heart failureHypertensive heart disease with (congestive) heart failureLeft ventricular failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06414265
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06414265 through Pure Global AI's free database. This phase not specified trial is sponsored by InnovHeart and is currently Recruiting. The study focuses on Heart Failure. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.