PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 17
- Primary Endpoint
- The percentage of patient treatment success rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be eligible to participate in this study, a recipient must meet all the following criteria:
- •Age ³18 years.
- •Signed informed consent form (ICF).
- •Listed for heart transplantation.
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 (IABP).
- •History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
- •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 participants meeting any of the following:
- •Participant with calculated Panel Reactive Antibody (cPRA) greater than 50%
- •Participant undergoing any desensitization treatment (also with cPRA less than 50%)
- •Participant with a positive prospective crossmatch and/or a positive virtual cross match
- •Donor Inclusion Criteria:
- •To be eligible to participate in this study, the donor heart must meet the following criteria:
- •Estimated Cross Clamp Time ≥4 hours OR
- •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:
- •Unstable hemodynamics requiring high-dose inotropic support.
- •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.
- •Moderate to severe cardiac valve pathology.
- •Investigator's clinical decision to exclude from trial.
- •Previous sternotomy.
Arms & Interventions
Device: Preservation of hearts for transplant.
Device: Preservation of hearts for transplant.
Intervention: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT) (Device)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported