New York, NYNCT06951672Now EnrollingIRB Ready

Symptomatic Functional MR 3 or Greater Clinical Trial in New York, NY

Access cutting-edge symptomatic functional mr 3 or greater treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Valcare Medical Ltd.

Quick Self-Assessment

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Preparing your pre-screening questions…

Expert Care in New York

Access symptomatic functional mr 3 or greater specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related symptomatic functional mr 3 or greater treatment provided free

Apply for This New York Location

Check if you qualify for this symptomatic functional mr 3 or greater clinical trial in New York, NY

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Symptomatic Functional MR 3 or Greater Study in New York

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.

Sponsor: Valcare Medical Ltd.

Who Can Participate

Inclusion Criteria

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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT06951672) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Symptomatic Functional MR 3 or Greater Treatment Options in New York, NY

If you're searching for symptomatic functional mr 3 or greater treatment options in New York, NY, this clinical trial (NCT06951672) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced symptomatic functional mr 3 or greater specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all symptomatic functional mr 3 or greater clinical trials near you to find additional studies recruiting in your area.

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