Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06093828
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-16
Brief Title:
Transcatheter Treatment of Tricuspid Valve Regurgitation
Sponsor:
TriFlo Cardiovascular Inc
Organization:
TriFlo Cardiovascular Inc
Study Overview
Official Title:
Transcatheter Treatment of Tricuspid Valve Regurgitation With the TriFlo Tricuspid Flow Optimizer TFO System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
Tricuspid Regurgitation induces an asymmetric enlargement of the tricuspid valve TV annulus causing a reduction of leaflets coaptation Annular dilation continues even after surgical treatment The progressive nature of TR inadequate surgical treatment and high-risk patient population make TR an ideal target for transcatheter therapy The TriFlo TFO System introduces a new concept for the treatment of tricuspid regurgitation Its commissural anchoring is designed to respect TV leaflet integrity mobility and maintain RV contractility
Detailed Description:
This study is a prospective single-arm multicenter pre-market study Recent epidemiological data estimate the prevalence of significant tricuspid regurgitation TR in the general population to be as high as 055 and up to 3 after 75 years of age a prevalence comparable to aortic stenosis AS or mitral regurgitation MR Although the prevalence is high TR is often not treated In the United States approximately 16 million patients live with moderate to severe TR and fewer than 8000 tricuspid surgeries are performed annually
Clinically relevant TR is present in approximately 30 million individuals in Europe and 70 million people worldwide Approximately 90 of TR in adults is functional secondary and can be due to left-sided myocardial or valvular disease pulmonary vascular disease right ventricular myopathychronic right ventricular volume overload or idiopathic Uncertainty about the impact of TR on outcomes is related to the heterogeneous nature of the tricuspid disease which is often secondary to other conditions mainly left-sided disease or pulmonary hypertension In spite of its high prevalence tricuspid valve disease is a largely untreated condition and is known to be associated with poor life expectancy
The purpose of this clinical study is to evaluate the safety and clinical efficacy of the TriFlo Tricuspid Flow Optimizer in the treatment of severe TR
Clinically relevant TR is present in approximately 30 million individuals in Europe and 70 million people worldwide Approximately 90 of TR in adults is functional secondary and can be due to left-sided myocardial or valvular disease pulmonary vascular disease right ventricular myopathychronic right ventricular volume overload or idiopathic Uncertainty about the impact of TR on outcomes is related to the heterogeneous nature of the tricuspid disease which is often secondary to other conditions mainly left-sided disease or pulmonary hypertension In spite of its high prevalence tricuspid valve disease is a largely untreated condition and is known to be associated with poor life expectancy
The purpose of this clinical study is to evaluate the safety and clinical efficacy of the TriFlo Tricuspid Flow Optimizer in the treatment of severe TR
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?:
None
Is an FDA AA801 Violation?:
None