Symptomatic Functional MR 3 or GreaterNCT06951672
AMEND TS Early Feasibility Study
A study testing This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation. in people with Symptomatic Functional MR 3 or Greater, run by Valcare Medical Ltd. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Symptomatic Functional MR 3 or Greater
- What is being tested?
- This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 11 sitesUnited States
- Study dates
- 11 Sep 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Not yet recruiting
Piedmont Healthcare
Atlanta, Georgia, 30309
Caryn Bernstein, Caryn.Bernstein@piedmont.org
Pradeep Yadav, MD
- Recruiting
University of Texas Health Science Center (UTH)
Houston, Texas, 77030
Anna Meneres, anna.m.menezes@uth.tmc.edu
Abhijeet Dhoble, MBBS, MPH, RPVI, FACP, FACC
- Recruiting
Ascension St. Vincent
Indianapolis, Indiana, 46260
Jena Stanley, jena.stanley@ascension.org
James Hermiller, MD, FACC
- Not yet recruiting
Scripps Health
La Jolla, California, 92037
Crystal Serneo, Serneo.Crystal@scrippshealth.org
Matthew Price, MD, FACC
- Not yet recruiting
Intermountain Health
Murray, Utah, 84107
Erika Hummel, Erika.Hummel@imail.org
Brian Whisenant, MD
- Not yet recruiting
Saint Thomas Research Institute
Nashville, Tennessee, 37205
Emily Normandin, emily.normandin@ascension.org
Evelio Rodriguez, MD, FACC
- Recruiting
Columbia University Medical Center (CUMC)
New York, New York, 10032
Krystal Garcia, kg3016@cumc.columbia.edu
Susheel Kodali, MD
- Recruiting
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006
Karen Moylen, kmoylen@arizona.edu
Paul Sorajja, MD
- Recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Ashtyn Chamberland, chamasht@ohsu.edu
Firas Zahr, MD
- Recruiting
Methodist Hospital HCA
San Antonio, Texas, 78229
Jaymee Lopez, jaymee.lopez@hcahealthcare.com
Jorge Alvarez, MD
- Not yet recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Tammy Rodriguez Guzman, tamrodrigu@montefiore.org
Mohamed Azeem Latib, MD
About this study
Official title: 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
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.
Read the 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
- Being tested
- This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.
- Keywords
- MR reduction, mitral regurgitation, Heart valve, annuloplasty ring, functional mitral regurgitation, mitral valve
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| prospective, single arm, open trial to evaluate the safety, functionality of the AMEND TS System | Experimental | 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. Receives: Device: This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint: Composite of death (all-cause), stroke, myocardial infarction (MI), or non-elective cardiovascular surgery for device related complications at 30 days.
The definitions of the SAEs are based on the recommendation of the Mitral Valve Academic Research Consortium (MVARC) (Stone, 2015).
Measured: 30 days
Secondary outcomes (1)
Secondary Endpoint: Performance Endpoint
Technical success of ring delivery, implantation and delivery system retrieval determined at the end of implantation procedure based on the following:
- Absence of procedural mortality
- Freedom from emergency surgery or corrective treatment related to the device or access procedure
- Successful access, delivery to the LA, and retrieval of the delivery system
- Correct positioning of the implant evaluated by echocardiography after procedure completion
- Adequate implant quadrant fixation evaluated by echocardiography after procedure completion
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start11 Sep 2025
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Functional MR 3 or GreaterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valcare Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. David Meerkin, CMO, MD, Study director, Valcare Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951672
- Sponsor's protocol ID
- CIP - 0001762
- Status last verified
- Jan 2026
- First submitted
- 4 Apr 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06951672
- Acronym / sponsor ID
- CIP - 0001762
- Conditions
- Symptomatic Functional MR 3 or Greater
- Keywords
- MR reduction, mitral regurgitation, Heart valve, annuloplasty ring, functional mitral regurgitation, mitral valve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Valcare Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prospective, single arm, open trial to evaluate the safety, functionality of the AMEND TS System | Experimental | Device: This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | prospective, single arm, open trial to evaluate the safety, functionality of the AMEND TS System |
Primary outcome
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
The definitions of the SAEs are based on the recommendation of the Mitral Valve Academic Research Consortium (MVARC) (Stone, 2015).
1 secondary outcome
Secondary Endpoint: Performance Endpoint
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. David Meerkin, CMO, MD study director
Valcare Medical
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation. in people with Symptomatic Functional MR 3 or Greater, run by Valcare Medical Ltd. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anat Eitan, VP RA & Clinical (+972546280106, aeitan@valcaremedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.