AMEND TS Early Feasibility Study

Recruiting now · Not applicable

Conditions studied: Symptomatic Functional MR 3 or Greater

In brief

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 facts

Study ID

NCT06951672

Run by

Valcare Medical Ltd.

People needed

15

Starts

2025-09-11

Expected to finish

2027-04-01

Last updated by the study team

2026-01-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Oregon Health & Science University (OHSU) — Portland, Oregon, United States (enrolling)
• Columbia University Medical Center (CUMC) — New York, New York, United States (enrolling)
• University of Texas Health Science Center (UTH) — Houston, Texas, United States (enrolling)
• Methodist Hospital HCA — San Antonio, Texas, United States (enrolling)
• Banner University Medical Center - Phoenix — Phoenix, Arizona, United States (enrolling)
• Ascension St. Vincent — Indianapolis, Indiana, United States (enrolling)
• Intermountain Health — Murray, Utah, United States
• Scripps Health — La Jolla, California, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Saint Thomas Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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