XVIVO Heart Assist Transport (XHAT) With Supplemented XVIVO Heart Solutuion (SXHS) Continued Access Protocol (CAP)

Not Applicable

Not yet recruiting

• Conditions: Heart Transplant; Heart Failure; Transplant; Failure, Heart

• Registration Number: NCT06895070
• Lead Sponsor: XVIVO Perfusion

Brief 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.

Detailed Description

This is a continuation of the PRESERVE IDE trial to provide additional data evaluating the safety and effectiveness of the XVIVO Heart Assist Transport System. The PRESERVE Continued Access Protocol (CAP) will utilize the XHAT System to preserve donor hearts that may not meet current standard donor heart acceptance criteria with the intention of these hearts being transplanted. The CAP has been implemented to allow patients and physicians access to the XHAT System while a Post-Market Approval (PMA) application is being submitted and reviewed.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-04-01
• Study Start: 2025-05
• Primary Completion: 2026-05
• Study Completion: 2031-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

To be eligible to participate in this study, the donor heart must meet the following criteria:

1. Estimated Cross Clamp Time ≥4 hours OR
2. Estimated Cross Clamp ≥ 2 hours AND

Any one or more of the following:

• Age ≥50 years
• LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance).
• Down-time ≥20 minutes
• Hypertrophy septal thickness >12 - ≤16mm
• Angiographic luminal irregularities with no significant CAD OR 1) Donation after Circulatory Death (DCD)

Donor

Exclusion Criteria

Donor hearts that meet any of the following criteria will be excluded from transplantation in this study:

1. Unstable hemodynamics requiring high-dose inotropic support.
2. Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels or if the donor heart exhibits any contusions, structural damage, gross abnormalities, or palpable CAD on final examination.
3. Moderate to severe cardiac valve pathology.
4. Investigator's clinical decision to exclude from trial.
5. Previous sternotomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The percentage of patient treatment success rate	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.
The percentage of patient survival	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.