XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05881278 |
Recruitment Status :
Recruiting
First Posted : May 31, 2023
Last Update Posted : April 25, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure Transplant; Failure, Heart | Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 141 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors |
Actual Study Start Date : | October 10, 2023 |
Estimated Primary Completion Date : | March 2026 |
Estimated Study Completion Date : | March 2030 |
Arm | Intervention/treatment |
---|---|
Experimental: Subjects requiring a Heart Transplant
Device: Preservation of hearts for transplant.
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Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) |
- The percentage of patient survival [ Time Frame: Post-operative Day 365. ]The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.
- The percentage of patient treatment success rate [ Time Frame: 30 days post transplantation ]The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Recipient Inclusion Criteria:
- Age ≥18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation
Recipient Exclusion Criteria:
- Previous solid organ or bone marrow transplantation.
- Requires a multi-organ transplant.
- Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
- Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump.
- History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion).
- Subject on renal replacement therapy/dialysis.
- Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
- Sensitized subject is undergoing desensitization treatment.
Donor Inclusion Criteria:
- Estimated Cross Clamp Time ≥ 4 hours, OR
-
Estimated Cross Clamp Time ≥ 2 hours, AND
Any ONE or more of the following:
- Age ≥ 50 years
- LVEF 40-50% at time of provisional acceptance
- Down-time ≥ 20 mins
- Hypertrophy/Septal thickness >12- ≤16mm
- Angiographic luminal irregularities with no significant CAD, OR
- Donation after Circulatory Death (DCD) donors.
Donor Exclusion Criteria:
- Unstable hemodynamics requiring high-dose inotropic support.
- Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels.
- Moderate to severe cardiac valve pathology.
- Investigator's clinical decision to exclude from trial.
- Previous Sternotomy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05881278
Contact: Sarah Lowe | 303-881-7700 | sarah.lowe@xvivogroup.com |
United States, California | |
University of California San Diego | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Connor Davies 858-246-0872 crdavies@health.ucsd.edu | |
Principal Investigator: Victor Pretorius, MD | |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Dasia Webster 404-295-7482 dkwebst@emory.edu | |
Principal Investigator: Mani Daneshmand, MD | |
United States, Illinois | |
Northwestern Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Allison Mossell allison.mossell@nm.org | |
Principal Investigator: Benjamin Bryner, MD | |
United States, New York | |
NYU Langone Health | Recruiting |
New York, New York, United States, 10016 | |
Contact: Jacqueline Bott 212-263-2268 jacqueline.bott@nyulangone.org | |
Principal Investigator: Nader Moazami, MD | |
Columbia University Irving Medical Center/New York Presbyterian Hospital | Recruiting |
New York, New York, United States, 10032 | |
Contact: Amanda Alonso, MHA, CCRC 212-342-0261 aa2974@cumc.columbia.edu | |
Principal Investigator: Koji Takeda, MD | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Susan Hajmohammad, BS 919-684-1988 susan.hajmohammad@duke.edu | |
Contact: Sarah Casalinova, BS 919-613-5621 sarah.casalinova@duke.edu | |
Principal Investigator: Jacob Schroder, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Kelli Cook kelli.cook@pennmedicine.upenn.edu | |
Principal Investigator: Pavan Atluri, MD | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Gail Wallen 412-647-8762 walleng@upmc.edu | |
Contact: Kristin Konopka 412-647-8762 valcharka@upmc.edu | |
Principal Investigator: David Kaczorowski, MD | |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Lisa Slinger 615-875-2602 lisa.slinger@vumc.org | |
Principal Investigator: Ashish Shah, MD |
Study Director: | Jaya Tiwari | XVIVO Perfusion |
Responsible Party: | XVIVO Perfusion |
ClinicalTrials.gov Identifier: | NCT05881278 |
Other Study ID Numbers: |
NIHP - 001 |
First Posted: | May 31, 2023 Key Record Dates |
Last Update Posted: | April 25, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Heart Failure Heart Diseases Cardiovascular Diseases |