Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414265
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-04-29
Brief Title:
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement TMVR System in Patients With Severe Symptomatic Mitral Regurgitation
Sponsor:
InnovHeart
Organization:
InnovHeart
Study Overview
Official Title:
Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-Septal TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - CASSINI-EU Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASSINI-EU
Brief 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
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
Detailed Description:
The SATURN Trans-Septal Transcatheter Mitral Valve Replacement System SATURN TS System is intended for use in adult patients suffering from heart failure symptoms NYHA class II or greater with moderate to severe or severe mitral regurgitation MR 3 who are deemed to be at high risk for open-heart mitral valve surgery by a multidisciplinary Heart Team including at least a cardiac surgeon and a cardiologist experienced in the care of patients with mitral valve disease
CASSINI-EU is a single-arm prospective multicenter pilot trial The purpose of the study 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
Primary objectives are to evaluate the feasibility safety and performance of the SATURN TS TMVR System at 30 days Secondary objectives and additional outcomes are long term safety and performance of the SATURN TS TMVR System
Up to 30 patients will be treated at up to 6 qualified investigational sites in Europe
CASSINI-EU is a single-arm prospective multicenter pilot trial The purpose of the study 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
Primary objectives are to evaluate the feasibility safety and performance of the SATURN TS TMVR System at 30 days Secondary objectives and additional outcomes are long term safety and performance of the SATURN TS TMVR System
Up to 30 patients will be treated at up to 6 qualified investigational sites in Europe
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None