Actively Recruiting
AMEND TS Early Feasibility Study
Led by Valcare Medical Ltd. · Updated on 2026-01-07
15
Participants Needed
11
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AMEND TS Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age over 21 years
- Benefit expected from isolated mitral valve annuloplasty without need for other cardiovascular surgeries
- Symptomatic functional mitral regurgitation grade 3 or higher
- NYHA functional class 2 or higher
- Left ventricular ejection fraction greater than 30% and left ventricular end-diastolic diameter less than 68 mm
- Meets anatomical criteria for implant size
- High surgical risk for mitral valve surgery as assessed by heart team
- Stable on heart failure medications for at least one month
- Femoral vein and transseptal access feasible
- Willing to comply with study procedures and follow-up visits
- Informed consent signed
You will not qualify if you...
- Mitral incompetence unsuitable for annuloplasty ring repair
- Major cardiac or non-cardiac progressive disease increasing risk
- Life expectancy less than 12 months
- Non-operable and ineligible for TEER procedure
- Heavily calcified mitral annulus or leaflets
- Previous or active endocarditis
- Active infection
- Prior prosthetic aortic valve or mitral intervention
- Cardiovascular intervention within 30 days before procedure
- Glomerular filtration rate less than 30 ml/min
- Ischemic coronary event within 30 days before procedure
- Significant coronary artery disease requiring revascularization
- Contraindication to general anesthesia
- Unable to take anti-platelet or anti-coagulant medications
- Known allergy to nickel
- Severe allergy to contrast media
- Significant right ventricle dysfunction
- Left atrial thrombus
- Cerebrovascular event within past 12 months
- Mitral valve anatomy unsuitable for AMEND treatment
- Pulmonary systolic hypertension with estimated SPAP above 70 mmHg at rest
- Pregnant or lactating women
- Drug or alcohol abuse
- Participation in other investigational research
- Planned cardiac surgery or interventions within next 7 months
- Recent implant or revision of cardiac rhythm device within prior month
- Hypotension or need for inotropic or mechanical support
- Status 1 or prior heart transplantation
- Contraindication or high risk for transesophageal echocardiography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Banner University Medical Center - Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Scripps Health
La Jolla, California, United States, 92037
Not Yet Recruiting
3
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Not Yet Recruiting
4
Ascension St. Vincent
Indianapolis, Indiana, United States, 46260
Actively Recruiting
5
Columbia University Medical Center (CUMC)
New York, New York, United States, 10032
Actively Recruiting
6
Montefiore Medical Center
The Bronx, New York, United States, 10467
Not Yet Recruiting
7
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
8
Saint Thomas Research Institute
Nashville, Tennessee, United States, 37205
Not Yet Recruiting
9
University of Texas Health Science Center (UTH)
Houston, Texas, United States, 77030
Actively Recruiting
10
Methodist Hospital HCA
San Antonio, Texas, United States, 78229
Actively Recruiting
11
Intermountain Health
Murray, Utah, United States, 84107
Not Yet Recruiting
Research Team
A
Anat Eitan, VP RA & Clinical
CONTACT
M
Madhuri Bhat
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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