Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation - Trial NCT06414265
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.
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Study Focus
Sponsor & Location
InnovHeart
Timeline & Enrollment
N/A
Apr 04, 2024
Feb 01, 2030
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
Data Source
ClinicalTrials.gov
NCT06414265
Device Trial