Cincinnati, OHNCT07503236Now EnrollingIRB Ready

Mitral Regurgitation Functional Clinical Trial in Cincinnati, OH

Access cutting-edge mitral regurgitation functional treatment through this clinical trial at a research site in Cincinnati. Study-provided care at no cost to qualified participants.

Sponsored by Nyra Medical, Inc.

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Expert Care in Cincinnati

Access mitral regurgitation functional specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related mitral regurgitation functional treatment provided free

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Check if you qualify for this mitral regurgitation functional clinical trial in Cincinnati, OH

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

Why Participate?

  • No-Cost Study Care

  • Local to Cincinnati

    Convenient for OH 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 Cincinnati site if eligible
  4. 4Begin participation

About This Mitral Regurgitation Functional Study in Cincinnati

Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.

Sponsor: Nyra Medical, Inc.

Who Can Participate

Inclusion Criteria

Age \> 21 years at time of enrollment
Patient has provided informed consent, is willing and capable of participating in all testing, and agrees to return for all required post-procedure follow-up visits
Moderate-to-severe or severe (MR ≥ 3+) functional (secondary) mitral valve regurgitation
Symptomatic with mitral regurgitation (NYHA Class II, III, or ambulatory IV) despite maximally-tolerated guideline-directed medical therapy (GDMT) as determined by the local multidisciplinary Heart Team
Patient is suitable for transcatheter mitral valve repair as determined by the local multidisciplinary Heart Team and confirmed by the Eligibility Committee Key

Exclusion Criteria

Estimated life expectancy of less than 12 months
Women who are pregnant, lactating, or planning to become pregnant during the clinical study. Women of child-bearing potential must have negative pregnancy test result within 2 weeks prior to the procedure
Left Ventricular Ejection Fraction (LVEF) \< 20%
Left ventricular end diastolic diameter (LVEDD) \> 75 mm
Acute hemodynamic decompensation
Known hypersensitivity or contraindications to necessary and routine medications including contrast compounds or components used in the CARLEN System that cannot be successfully pre-medicated, including nitinol, an alloy of nickel and titanium
Contraindicated for transesophageal echo (TEE)
Presence of other anatomical characteristics and/or significant comorbidities that in the judgement of the Investigator or Eligibility Committee precludes the subject from participation
Aortic valve disease requiring intervention or intervention
Severe or greater tricuspid regurgitation
Severe right ventricular dysfunction
Severe pulmonary hypertension
Presence of significant congenital heart disease
Planned or scheduled cardiac surgery within next 12 months
Endocarditis within last 90 days
Evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease

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 Cincinnati?

Yes, this clinical trial (NCT07503236) has an active research site in Cincinnati, OH 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.

Mitral Regurgitation Functional Treatment Options in Cincinnati, OH

If you're searching for mitral regurgitation functional treatment options in Cincinnati, OH, this clinical trial (NCT07503236) 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 Cincinnati research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mitral regurgitation functional 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 mitral regurgitation functional clinical trials near you to find additional studies recruiting in your area.

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Secure · Expert Care · Cincinnati, OH