AMEND TS Early Feasibility Study

Conditions

• Symptomatic Functional MR 3 or Greater

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation. — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Sep 11, 2025

Status verified

Jan 2026

Primary completion

Oct 31, 2026

Completion

Apr 30, 2027

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: prospective, single arm, open trial to evaluate the safety, functionality of the AMEND TS System
  The AMEND TS EFS is a prospective, single arm, open clinical trial designed to evaluate the safety and functionality of the AMENDTM Trans-Septal System for MR reduction in patients suffering from functional mitral regurgitation. This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.

Primary Outcome Measure

Safety Endpoint: Composite of death (all-cause), stroke, myocardial infarction (MI), or non-elective cardiovascular surgery for device related complications at 30 days. [ Time Frame: 30 days ]

Central Contacts

• Anat Eitan, VP RA & Clinical
  +972546280106
  [email protected]
• Madhuri Bhat
  408-230-2442
  [email protected]

Locations (11)

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