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New treatment option for Heart Transplant
Official title Enhancing Heart Allograft Function With the OCS Heart System Trial
ClinicalTrials.gov ID: NCT07145515
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part A - DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications): Donor Donor hearts are...
- All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is...
- 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
See the full eligibility criteria
- Part A - DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications): Donor Donor hearts are deemed clinically acceptable for transplantation after physical...
- 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...
- 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 Moderate to severe aortic incompetence Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication): Donor Donor hearts are deemed clinically acceptable for transplantation...
- 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 treatment clinical or investigational trials/programs that may confound the outcomes of this trial
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Valhalla, New York, United States
- Durham, North Carolina, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; New York, New York, United States; Valhalla, New York, United States; Durham, North Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.