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Status:

RECRUITING

AMEND TS Early Feasibility Study

Lead Sponsor:

Valcare Medical Ltd.

Conditions:

Symptomatic Functional MR 3 or Greater

Eligibility:

All Genders

21+ years

Phase:

NA

Brief 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 ...

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 ...

Eligibility Criteria

Inclusion

  • Patient age \>21
  • The patient will benefit from isolated mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures such as coronary artery bypass or another valve reconstruction or replacement
  • Symptomatic functional MR≥3+
  • NYHA functional capacity ≥2
  • LV Ejection Fraction \> 30%, LVEDD \< 68 mm
  • The subject meets the anatomical eligibility criteria for available implant size(s)
  • The subject is at high risk for mitral valve surgery as assessed by the center's heart team for mitral procedures.
  • The subject has been stable and on a stable pharmacological regimen for heart failure for at least 1 month prior to inclusion
  • Femoral vein access and transseptal device access is determined to be feasible by the implanting investigator
  • The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits
  • Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.

Exclusion

  • The patient has mitral incompetence where an annuloplasty ring will not contribute to its repair
  • Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
  • Life expectancy of less than 12 months
  • The subject is non-operable and is not eligible for TEER, to allow bailout
  • Heavily calcified mitral annulus or leaflets
  • Previous or active endocarditis.
  • Active infection
  • A previously implanted prosthetic aortic valve or mitral intervention
  • Cardiovascular intervention within 30 days prior to study procedure
  • GFR \<30 ml/min
  • The patient has had an ischemic coronary event within 30 days prior to study procedure
  • The patient has clinically significant coronary artery disease requiring re- vascularization
  • The subject is contraindicated to general anesthesia
  • The subject is unable to take anti-platelet or anti-coagulant medications
  • A known allergy to nickel
  • Severe allergy to contrast media
  • Significant right ventricle dysfunction
  • Left atrial thrombus
  • A cerebral vascular event (CVA or TIA) within the past 12 months
  • A mitral valve anatomy which may preclude proper AMEND™ treatment
  • Pulmonary systolic hypertension (estimated SPAP \> 70 mmHg at rest), determined by echocardiography
  • Pregnant (for women in the reproductive age, blood HCG test result positive) or lactating patient
  • Drug or alcohol abuse
  • Participation in concomitant research studies of investigational products
  • Any planned cardiac surgery or interventions within the next 7 months
  • Implant or revision of any rhythm management device (cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy device (CRT-D)) or implantable cardioverter defibrillator within the prior month
  • Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support
  • Status 1 heart transplantation or prior orthotopic heart transplantation
  • Subjects in whom transesophageal echocardiography is contraindicated or high risk

Key Trial Info

Start Date :

September 11 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT06951672

Start Date

September 11 2025

End Date

April 1 2027

Last Update

January 7 2026

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Banner University Medical Center - Phoenix

Phoenix, Arizona, United States, 85006

2

Scripps Health

La Jolla, California, United States, 92037

3

Piedmont Healthcare

Atlanta, Georgia, United States, 30309

4

Ascension St. Vincent

Indianapolis, Indiana, United States, 46260