Lexington, KYNCT02744677Now EnrollingIRB Ready

Complex Congenital Heart Defect Clinical Trial in Lexington, KY

Access cutting-edge complex congenital heart defect treatment through this clinical trial at a research site in Lexington. Study-provided care at no cost to qualified participants.

Sponsored by Edwards Lifesciences

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Expert Care in Lexington

Access complex congenital heart defect specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related complex congenital heart defect treatment provided free

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Check if you qualify for this complex congenital heart defect clinical trial in Lexington, KY

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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 Lexington

    Convenient for KY 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 Lexington site if eligible
  4. 4Begin participation

About This Complex Congenital Heart Defect Study in Lexington

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Sponsor: Edwards Lifesciences

Who Can Participate

Inclusion Criteria

Weight ≥ 20 kg (44 lbs.)
Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
History of or active endocarditis (active treatment with antibiotics) within the past 180 days
Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
Inappropriate anatomy for femoral introduction and delivery of the study valve
Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
Interventional/surgical procedures within 30 days prior to the TPVI procedure.
Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
History of or current intravenous drug use
Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
Participating in another investigational drug or device study that has not reached its primary endpoint.
Female who is lactating or pregnant

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 Lexington?

Yes, this clinical trial (NCT02744677) has an active research site in Lexington, KY 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.

Complex Congenital Heart Defect Treatment Options in Lexington, KY

If you're searching for complex congenital heart defect treatment options in Lexington, KY, this clinical trial (NCT02744677) 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 Lexington research site is actively enrolling participants for this clinical trial. You'll receive care from experienced complex congenital heart defect 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.

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Secure · Expert Care · Lexington, KY