Donors After Circulatory Death Heart Trial

NCT03831048 | Completed Results DMC FDA Device

• 1 other identifier: OCS-CAR-03202019
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 25

Brief Summary

To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

Conditions

Heart Transplant

Keywords

Heart preservation; Beating heart transplant

Outcome Measures

Primary Outcomes (1)

• Survival

  Patient survival 6 months post-transplant

  6 months

Secondary Outcomes (1)

• Utilization Rate

  Within 24 hours post-transplant

Study Arms (2)

DCD Heart Possible

EXPERIMENTAL

Device: OCS Heart System

Standard of Care Heart Only

ACTIVE COMPARATOR

Other: Cold Storage

Interventions

OCS Heart System DEVICE

Preserving and assessing donor after circulatory death hearts for transplant

DCD Heart Possible

Cold Storage OTHER

Active comparator intervention

Standard of Care Heart Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Donor Inclusion * Maastricht Category III DCD donor, defined as expected death after the withdrawal of life- supportive therapy (WLST) * Donor age 18-49 years old inclusive * Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor. Donor Exclusion * Previous cardiac surgery * Known coronary artery disease * Cardiogenic shock or myocardial infarction, or * Sustained terminal ejection fraction (EF) of ≤ 50%, or * Significant valve disease except for competent bicuspid aortic valve Recipient Inclusion * Primary heart transplant candidates * Age ≥ 18 years old * Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data. Recipient Exclusion * Prior solid organ or bone marrow transplant * Chronic use of hemodialysis or diagnosis of chronic renal insufficiency * Multi-organ transplant * Investigator unwilling to randomize to either arm.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• TransMedics: lead

Study Sites (25)

University of California San Diago

La Jolla, California, 92037, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

AdventHealth

Orlando, Florida, 32804, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

St. Vincent Cardiovascular Research Institute

Indianapolis, Indiana, 46260, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Nyph/Cumc

New York, New York, 10032, United States

Location

Montefiore

The Bronx, New York, 10467, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Sentara

Norfolk, Virginia, 23502, United States

Location

Virgina Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• Merani S, Urban M, Westphal SG, Dong J, Miles CD, Maskin A, Hoffman A, Langnas AN. Improved Early Post-Transplant Outcomes and Organ Use in Kidney Transplant Using Normothermic Regional Perfusion for Donation after Circulatory Death: National Experience in the US. J Am Coll Surg. 2024 Jan 1;238(1):107-118. doi: 10.1097/XCS.0000000000000880. Epub 2023 Sep 29.

  PMID: 37772721 DERIVED

• Schroder JN, Patel CB, DeVore AD, Bryner BS, Casalinova S, Shah A, Smith JW, Fiedler AG, Daneshmand M, Silvestry S, Geirsson A, Pretorius V, Joyce DL, Um JY, Esmailian F, Takeda K, Mudy K, Shudo Y, Salerno CT, Pham SM, Goldstein DJ, Philpott J, Dunning J, Lozonschi L, Couper GS, Mallidi HR, Givertz MM, Pham DT, Shaffer AW, Kai M, Quader MA, Absi T, Attia TS, Shukrallah B, Sun BC, Farr M, Mehra MR, Madsen JC, Milano CA, D'Alessandro DA. Transplantation Outcomes with Donor Hearts after Circulatory Death. N Engl J Med. 2023 Jun 8;388(23):2121-2131. doi: 10.1056/NEJMoa2212438.

  PMID: 37285526 DERIVED

• Shudo Y, Benjamin-Addy R, Koyano TK, Hiesinger W, MacArthur JW, Woo YJ. Donors after circulatory death heart trial. Future Cardiol. 2021 Jan;17(1):11-17. doi: 10.2217/fca-2020-0070. Epub 2020 Jul 6.

  PMID: 32628044 DERIVED

MeSH Terms

Interventions

Cryopreservation

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Laura Damme
• Organization: TransMedics, Inc.

ldamme@transmedics.com

9785520900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 5, 2019
• Study Start: November 26, 2019
• Primary Completion: April 1, 2021
• Study Completion: September 28, 2021
• Last Updated: May 7, 2024
• Results First Posted: May 7, 2024

Record last verified: 2022-12

Locations

US (25)