XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881278
• Other study ID #: NIHP - 001
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: March 2030

Study information

• Verified date: April 2024
• Source: XVIVO Perfusion
• Contact: Sarah Lowe
• Phone: 303-881-7700
• Email: sarah.lowe[@]xvivogroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.

Description:

PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: March 2030
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Recipient Inclusion Criteria:

1. Age =18 years.

2. Signed informed consent form (ICF).

3. Listed for heart transplantation

Recipient Exclusion Criteria:

1. Previous solid organ or bone marrow transplantation.

2. Requires a multi-organ transplant.

3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).

4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump.

5. History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion).

6. Subject on renal replacement therapy/dialysis.

7. Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).

8. Sensitized subject is undergoing desensitization treatment.

Donor Inclusion Criteria:

1. Estimated Cross Clamp Time = 4 hours, OR

2. 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

3. Donation after Circulatory Death (DCD) donors.

Donor Exclusion Criteria:

1. Unstable hemodynamics requiring high-dose inotropic support.

2. Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels.

3. Moderate to severe cardiac valve pathology.

4. Investigator's clinical decision to exclude from trial.

5. Previous Sternotomy.

Related Conditions & MeSH terms

• Heart Failure
• Transplant; Failure, Heart

Intervention

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)

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	University of California San Diego	La Jolla	California
United States	Vanderbilt University	Nashville	Tennessee
United States	Columbia University Irving Medical Center/New York Presbyterian Hospital	New York	New York
United States	NYU Langone Health	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
XVIVO Perfusion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patient survival	The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.	Post-operative Day 365.
Primary	The percentage of patient treatment success rate	The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.	30 days post transplantation