NCT06951672

AMEND TS Early Feasibility Study

The AMEND TS Early Feasibility Study is a Prospective, Single-arm, Multi-center Study to Evaluate the Safety and Function of the AMEND(TM) Trans-Septal System for MR Reduction; Up to 15 Subjects Will be Enrolled in up to 7 Investigational Centers in the U.S. and Canada With a 30d Safety Endpoint

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Valcare Medical Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.

Detailed description

Objective: The purpose of this clinical investigation, the AMEND TS Early Feasibility Study, is to evaluate the safety and functionality of the AMEND Trans-Septal System for annuloplasty as treatment of mitral regurgitation. Device Description: The AMENDTM Trans-Septal System consists of a semi-rigid annuloplasty ring (implant), a delivery system (catheter), and accessories (Stage, Introducer sheath). The device is delivered through a catheter using a trans-septal approach and implanted in the beating heart on the atrial surface of the mitral valve annulus similar to surgical annuloplasty rings. Indications for Use: The device is indicated to treat patients with mitral regurgitation using a percutaneous direct annuloplasty approach Number of subjects and sites: Up to fifteen (15) subjects will be enrolled to the study procedure in up to 7 investigational centers in the U.S. and Canada Study Population: Subjects with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation that is anatomically amenable to transcatheter mitral annuloplasty. Study Duration: 5 years

Conditions

• Symptomatic Functional MR 3 or Greater

Interventions

Type	Name	Description
DEVICE	This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.	The ability to deploy the annuloplasty ring in a percutaneous fashion affords an improved safety profile for surgical candidates, as well as surgical style solution for those patients that are at elevated risk for surgery due to comorbidities and advanced age. This early feasibility study allows treatment of higher risk surgical candidates with a surgical- level annuloplasty repair therapy by the AMEND™ Implant.

Timeline

• Start date: 2025-09-11
• Primary completion: 2026-10-01
• Completion: 2027-04-01
• First posted: 2025-04-30
• Last updated: 2026-01-07

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study