Durham, NCNCT07145515Now EnrollingIRB Ready

Heart Transplant Clinical Trial in Durham, NC

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

Sponsored by TransMedics

Quick Self-Assessment

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Expert Care in Durham

Access heart transplant specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related heart transplant treatment provided free

Apply for This Durham Location

Check if you qualify for this heart transplant clinical trial in Durham, NC

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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 Durham

    Convenient for NC 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 Durham site if eligible
  4. 4Begin participation

About This Heart Transplant Study in Durham

This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.

Sponsor: TransMedics

Who Can Participate

Inclusion Criteria

Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is \<50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor.
DBD donor hearts with an expected cross clamp of ≥ 4 hours
DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time:
Donor age ≥ 40 years old
Unknown downtime
Insignificant CAD
LVEF ≤ 50% Donor

Exclusion Criteria

• Moderate to severe aortic incompetence Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication): Donor Inclusion Criteria
Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
Eligible for randomization to OCS or SCS treatment arms.
DBD donor hearts with an expected cross clamp time of \< 4 hours. Donor Exclusion
Moderate to severe aortic incompetence
DBD donor with any of the following organ quality concerns:
Donor age ≥ 40 years old
Unknown downtime
Insignificant CAD
LVEF ≤ 50% Recipient Eligibility Criteria (for Part A and B Cohorts) Inclusion
Signed informed consent document and authorization to use and disclose protected health information
Heart transplant candidate
Age ≥ 18 years old Exclusion • Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial

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 Durham?

Yes, this clinical trial (NCT07145515) has an active research site in Durham, NC 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.

Heart Transplant Treatment Options in Durham, NC

If you're searching for heart transplant treatment options in Durham, NC, this clinical trial (NCT07145515) 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 Durham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart transplant 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 heart transplant clinical trials near you to find additional studies recruiting in your area.

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Secure · Expert Care · Durham, NC