Heart DiseasesGUARDIANNCT04141605
Global Utilization And Registry Database for Improved heArt preservatioN
An observational study of Heart Diseases and Heart Failure, run by Paragonix Technologies at 22 sites in 4 countries.
Trial summary
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases, Heart Failure, Heart Defects, Congenital
- What is being tested?
- SherpaPak Cardiac Transport System
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 14 Feb 2020to 31 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients registered on the heart transplant registry who receive a heart transplant at a participating center and do not meet any of the exclusion criteria.
Who may be able to join
- Donor and donor hearts matched to the prospective recipient based upon institutional medical practice
- Registered male or female primary heart transplant candidates including pediatric candidates
Who cannot join
- Donor and donor hearts that do not meet institutional clinical requirements for transplantation
- When safe connection with the aorta cannot be made, e.g., due to lack of enough length of the aortic root
- Patients who are incarcerated persons (prisoners)
- Patients who have had a previous organ transplant
Trial locations and contacts
22 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 4 countries
United States17 sites
Tufts University Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Baylor University Medical Center
Dallas, Texas, 75246
Duke University
Durham, North Carolina, 27708
Lutheran Hospital
Fort Wayne, Indiana, 46804
University of Florida Health Shands Hospital
Gainesville, Florida, 32608
Spectrum Health
Grand Rapids, Michigan, 49503
Mayo Clinic
Jacksonville, Florida, 32224
Kansas University Medical Center
Lawrence, Kansas, 66045
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
NewYork-Presbyterian Columbia University Irving Medical Center
New York, New York, 10032
Sentara Healthcare
Norfolk, Virginia, 23507
AdventHealth Orlando
Orlando, Florida, 32803
Stanford University
Stanford, California, 94305
Pennslyvania State University
State College, Pennsylvania, 16801
Medstar Washington Hospital
Washington D.C., District of Columbia, 20010
Austria2 sites
University of Graz
Graz, 8036
Allgemeines Krankenhaus Wien
Vienna, 1090
Spain2 sites
Hospital Universitario 12 de Octubre
Madrid
Hospital Clínico Universitario de Valladolid
Valladolid
About this study
Official title: Global Utilization and Registry Database for Improved Heart Preservation
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.
CONCERT DCD is a substudy designed to assess the safety and feasibility of a direct procurement method for donation after circulatory death (DCD) heart procurement (CONCERT DCD) that utilizes preservation in a SherpaPak Cardiac Transport System. This DCD Substudy will be limited to approved GUARDIAN-Heart Registry sites who have been qualified to participate. The DCD Substudy will include prospective recipient identification and documentation of informed consent.
Read the detailed description
This study is a registry study collecting data both retrospectively from patients already transplanted and prospectively from consecutively enrolled patients for heart transplantation. The study is a chart review study.
Ongoing eligible recipients will undergo heart transplantation according to standard practices at each participating institution.
This study will be conducted at an estimated 25 institutions globally and will have about up to 3000 patients. Subjects will be followed from transplant through one-year post-transplantation (i.e., 24 hours post-transplant, discharge, 30-days, 1-year, 2-years, 3-years, 4-years, 5-years).
GUARDIAN provides critical and contemporary data on patient outcomes, with additional insight into risk factors and patient-related indices. Both donor and recipient information along with procedural details (including transportation) will be collected to provide information for major discrete endpoints such as death, primary graft dysfunction, right ventricular dysfunction, CPB weaning, Inotrope use, CAV diagnosis, rejection, and survival.
Information about re-hospitalizations and re-transplantations is vital to address the integrated endpoint of days alive out of hospital, which is particularly relevant for this patient population. In addition, the number of in-hospital days and ICU time is closely tracked as the major resource utilized, after the initial transplant.
CONCERT DCD Substudy:
CONCERT DCD, Cold Oxygenated Flush, No reanimation, Controlled Preservation Technique for DCD , is a cold oxygenated non-reanimation perfusion method using blood, bicarbonate and Wisconsin (UW) Preservation Solution. Hearts are procured following a cold, buffered blood flush (150 mL/min for approximately 20 minutes), followed by arrest with standard UW preservative. This utilizes a simplified perfusion circuit consisting of a centrifugal pump, reservoir, oxygenator, and heater/cooler. The same datapoints will be collected for this study. In addition to the Donor and Recipient inclusion criteria in the overall GUARDIAN heart registry, the following additional criteria will be required in the CONCERT DCD Substudy:
Recipient: Status 1 or 2
Recipients with Congenital heart etiologies will be excluded.
Donors: Aged 16-40
Anticipated total ischemic time (cross clamp time) <5 hours
Echo-confirmed functionally normal heart
No prior coronary disease, including significant valvular or ventricular dysfunction
- Conditions
- Heart Diseases, Heart Failure, Heart Defects, Congenital
- Being tested
- SherpaPak Cardiac Transport System
- Medical subject headings
- Heart Diseases, Heart Failure, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SherpaPak Cardiac Transport SystemDevice
Also called SherpaPak CTS
The Paragonix SherpaPak Cardiac Transport System ("SherpaPak CTS") is an ultraportable hypothermic preservation and transport system intended for use with donor hearts. The device is a legally marketed, FDA cleared medical device in the United States and CE Marked medical device in the European Union.
The SherpaPak CTS consists of multiple components: 1) outer transport shipper which contains within various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly which provides a rigid barrier enclosure in which the heart is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts, 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart is stored during transport, and 4) four size heart connectors designed to accommodate various size aortic stem diameters by which donor hearts are attached.
| Study group | Role | What they receive |
|---|---|---|
| SherpaPak CTS Patients | Patients whose donor heart was transported with the SherpaPak CTS Receives: Device: SherpaPak Cardiac Transport System | |
| Standard Transport Patients | Patients whose donor heart was transported with a method other than SherpaPak CTS in the past two years | |
| CONCERT DCD | Patients whose DCD heart was procured using a cold oxygenated flush with no reanimation and then transported in the SherpaPak CTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Primary Graft Dysfunction
Less than 40% LVEF by echocardiography or hemodynamics with RAP greater than 15 mm Hg, PCWP greater than 20 mm Hg, CI less thann 2 L/min/m^2, hypotension with MAP less than 70 mm Hg (lasting more than 1 hour)
Measured: one year
Number of Patients with Right Ventricular Dysfunction
hemodynamics with RAP grater than 15mm Hg, PCWP less than 15 mm Hg, CI less than 2 L/min/m^2, TPG less than 15mm Hg/pulmonary artery systolic pressure less than 50 mmHg OR need for RVAD
Measured: one year
Length of ICU Stay
Length of time patient admitted to the intensive care unit post transplant
Measured: one year
Length of Hospital Stay
Length of time before patient is discharged from the hospital post transplant
Measured: one year
Survival
The length of patient survival up to 5 years will be compared
Measured: 5 years
Secondary outcomes (3)
Hospitalizations
Number of related hospitalizations post transplant
Measured: one year
CAV development
Number of patients who developed CAV between 1 and 5 years post transplant will be compared
Measured: five years
Retransplant
The number of patients who were retransplanted will be compared
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start14 Feb 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Paragonix Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Zuckermann, MD, Principal investigator, ALLGEMEINES KRANKENHAUS WIEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141605
- Sponsor's protocol ID
- PGX-002
- Acronym
- GUARDIAN
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will only be released as a summary of the results found at each center and overall. No individual patient data will be released.
Publications
DeFilippis EM, Rodrigo ME, Loyaga-Rendon R, Shudo Y, Uriel N, Takeda K, D'Alessandro DA, Fiedler A. Preservation Strategy and Sex-Specific Risk of Severe Primary Graft Dysfunction After Heart Transplantation: A GUARDIAN-Heart Analysis. ASAIO J. 2026 May 13. doi: 10.1097/MAT.0000000000002736. Online ahead of print.
PubMed 42127213Lerman JB, Patel CB, Casalinova S, Nicoara A, Holley CL, Leacche M, Silvestry S, Zuckermann A, D'Alessandro DA, Milano CA, Schroder JN, DeVore AD. Early Outcomes in Patients With LVAD Undergoing Heart Transplant via Use of the SherpaPak Cardiac Transport System. Circ Heart Fail. 2024 May;17(5):e010904. doi: 10.1161/CIRCHEARTFAILURE.123.010904. Epub 2024 Apr 11.
PubMed 38602105D'Alessandro D, Schroder J, Meyer DM, Vidic A, Shudo Y, Silvestry S, Leacche M, Sciortino CM, Rodrigo ME, Pham SM, Copeland H, Jacobs JP, Kawabori M, Takeda K, Zuckermann A. Impact of controlled hypothermic preservation on outcomes following heart transplantation. J Heart Lung Transplant. 2024 Jul;43(7):1153-1161. doi: 10.1016/j.healun.2024.03.010. Epub 2024 Mar 19.
PubMed 38503386Moayedifar R, Shudo Y, Kawabori M, Silvestry S, Schroder J, Meyer DM, Jacobs JP, D'Alessandro D, Zuckermann A. Recipient Outcomes With Extended Criteria Donors Using Advanced Heart Preservation: An Analysis of the GUARDIAN-Heart Registry. J Heart Lung Transplant. 2024 Apr;43(4):673-680. doi: 10.1016/j.healun.2023.12.013. Epub 2023 Dec 30.
PubMed 38163452Shudo Y, Leacche M, Copeland H, Silvestry S, Pham SM, Molina E, Schroder JN, Sciortino CM, Jacobs JP, Kawabori M, Meyer DM, Zuckermann A, D'Alessandro DA. A Paradigm Shift in Heart Preservation: Improved Post-transplant Outcomes in Recipients of Donor Hearts Preserved With the SherpaPak System. ASAIO J. 2023 Nov 1;69(11):993-1000. doi: 10.1097/MAT.0000000000002036. Epub 2023 Apr 5.
PubMed 37678260
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Utilization and Registry Database for Improved Heart Preservation
- ClinicalTrials.gov ID
- NCT04141605
- Acronym / sponsor ID
- GUARDIAN / PGX-002
- Conditions
- Heart Diseases, Heart Failure, Heart Defects, Congenital
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Paragonix TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.
CONCERT DCD is a substudy designed to assess the safety and feasibility of a direct procurement method for donation after circulatory death (DCD) heart procurement (CONCERT DCD) that utilizes preservation in a SherpaPak Cardiac Transport System. This DCD Substudy will be limited to approved GUARDIAN-Heart Registry sites who have been qualified to participate. The DCD Substudy will include prospective recipient identification and documentation of informed consent.
Detailed description
This study is a registry study collecting data both retrospectively from patients already transplanted and prospectively from consecutively enrolled patients for heart transplantation. The study is a chart review study.
Ongoing eligible recipients will undergo heart transplantation according to standard practices at each participating institution.
This study will be conducted at an estimated 25 institutions globally and will have about up to 3000 patients. Subjects will be followed from transplant through one-year post-transplantation (i.e., 24 hours post-transplant, discharge, 30-days, 1-year, 2-years, 3-years, 4-years, 5-years).
GUARDIAN provides critical and contemporary data on patient outcomes, with additional insight into risk factors and patient-related indices. Both donor and recipient information along with procedural details (including transportation) will be collected to provide information for major discrete endpoints such as death, primary graft dysfunction, right ventricular dysfunction, CPB weaning, Inotrope use, CAV diagnosis, rejection, and survival.
Information about re-hospitalizations and re-transplantations is vital to address the integrated endpoint of days alive out of hospital, which is particularly relevant for this patient population. In addition, the number of in-hospital days and ICU time is closely tracked as the major resource utilized, after the initial transplant.
CONCERT DCD Substudy:
CONCERT DCD, Cold Oxygenated Flush, No reanimation, Controlled Preservation Technique for DCD , is a cold oxygenated non-reanimation perfusion method using blood, bicarbonate and Wisconsin (UW) Preservation Solution. Hearts are procured following a cold, buffered blood flush (150 mL/min for approximately 20 minutes), followed by arrest with standard UW preservative. This utilizes a simplified perfusion circuit consisting of a centrifugal pump, reservoir, oxygenator, and heater/cooler. The same datapoints will be collected for this study. In addition to the Donor and Recipient inclusion criteria in the overall GUARDIAN heart registry, the following additional criteria will be required in the CONCERT DCD Substudy:
Recipient: Status 1 or 2
Recipients with Congenital heart etiologies will be excluded.
Donors: Aged 16-40
Anticipated total ischemic time (cross clamp time) <5 hours
Echo-confirmed functionally normal heart
No prior coronary disease, including significant valvular or ventricular dysfunction
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SherpaPak CTS Patients | – | Device: SherpaPak Cardiac Transport SystemPatients whose donor heart was transported with the SherpaPak CTS |
| Standard Transport Patients | – | –Patients whose donor heart was transported with a method other than SherpaPak CTS in the past two years |
| CONCERT DCD | – | –Patients whose DCD heart was procured using a cold oxygenated flush with no reanimation and then transported in the SherpaPak CTS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients registered on the heart transplant registry who receive a heart transplant at a participating center and do not meet any of the exclusion criteria.
Key inclusion criteria (2 listed)
- Donor and donor hearts matched to the prospective recipient based upon institutional medical practice
- Registered male or female primary heart transplant candidates including pediatric candidates
Key exclusion criteria (4 listed)
- Donor and donor hearts that do not meet institutional clinical requirements for transplantation
- When safe connection with the aorta cannot be made, e.g., due to lack of enough length of the aortic root
- Patients who are incarcerated persons (prisoners)
- Patients who have had a previous organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SherpaPak Cardiac Transport SystemAlso: SherpaPak CTSThe Paragonix SherpaPak Cardiac Transport System ("SherpaPak CTS") is an ultraportable hypothermic preservation and transport system intended for use with donor hearts. The device is a legally marketed, FDA cleared medical device in the United States and CE Marked medical device in the European Union. The SherpaPak CTS consists of multiple components: 1) outer transport shipper which contains within various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly which provides a rigid barrier enclosure in which the heart is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts, 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart is stored during transport, and 4) four size heart connectors designed to accommodate various size aortic stem diameters by which donor hearts are attached. | Device | SherpaPak CTS Patients |
Primary outcome
Number of Patients with Primary Graft Dysfunction
Time frame: one year
Less than 40% LVEF by echocardiography or hemodynamics with RAP greater than 15 mm Hg, PCWP greater than 20 mm Hg, CI less thann 2 L/min/m^2, hypotension with MAP less than 70 mm Hg (lasting more than 1 hour)
Number of Patients with Right Ventricular Dysfunction
Time frame: one year
hemodynamics with RAP grater than 15mm Hg, PCWP less than 15 mm Hg, CI less than 2 L/min/m^2, TPG less than 15mm Hg/pulmonary artery systolic pressure less than 50 mmHg OR need for RVAD
Length of ICU Stay
Time frame: one year
Length of time patient admitted to the intensive care unit post transplant
Length of Hospital Stay
Time frame: one year
Length of time before patient is discharged from the hospital post transplant
Survival
Time frame: 5 years
The length of patient survival up to 5 years will be compared
3 secondary outcomes
Hospitalizations
Time frame: one year
CAV development
Time frame: five years
Retransplant
Time frame: five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 42127213DeFilippis EM, Rodrigo ME, Loyaga-Rendon R, Shudo Y, Uriel N, Takeda K, D'Alessandro DA, Fiedler A. Preservation Strategy and Sex-Specific Risk of Severe Primary Graft Dysfunction After Heart Transplantation: A GUARDIAN-Heart Analysis. ASAIO J. 2026 May 13. doi: 10.1097/MAT.0000000000002736. Online ahead of print.
- Derived from this study: PubMed 38602105Lerman JB, Patel CB, Casalinova S, Nicoara A, Holley CL, Leacche M, Silvestry S, Zuckermann A, D'Alessandro DA, Milano CA, Schroder JN, DeVore AD. Early Outcomes in Patients With LVAD Undergoing Heart Transplant via Use of the SherpaPak Cardiac Transport System. Circ Heart Fail. 2024 May;17(5):e010904. doi: 10.1161/CIRCHEARTFAILURE.123.010904. Epub 2024 Apr 11.
- Derived from this study: PubMed 38503386D'Alessandro D, Schroder J, Meyer DM, Vidic A, Shudo Y, Silvestry S, Leacche M, Sciortino CM, Rodrigo ME, Pham SM, Copeland H, Jacobs JP, Kawabori M, Takeda K, Zuckermann A. Impact of controlled hypothermic preservation on outcomes following heart transplantation. J Heart Lung Transplant. 2024 Jul;43(7):1153-1161. doi: 10.1016/j.healun.2024.03.010. Epub 2024 Mar 19.
- Derived from this study: PubMed 38163452Moayedifar R, Shudo Y, Kawabori M, Silvestry S, Schroder J, Meyer DM, Jacobs JP, D'Alessandro D, Zuckermann A. Recipient Outcomes With Extended Criteria Donors Using Advanced Heart Preservation: An Analysis of the GUARDIAN-Heart Registry. J Heart Lung Transplant. 2024 Apr;43(4):673-680. doi: 10.1016/j.healun.2023.12.013. Epub 2023 Dec 30.
- Derived from this study: PubMed 37678260Shudo Y, Leacche M, Copeland H, Silvestry S, Pham SM, Molina E, Schroder JN, Sciortino CM, Jacobs JP, Kawabori M, Meyer DM, Zuckermann A, D'Alessandro DA. A Paradigm Shift in Heart Preservation: Improved Post-transplant Outcomes in Recipients of Donor Hearts Preserved With the SherpaPak System. ASAIO J. 2023 Nov 1;69(11):993-1000. doi: 10.1097/MAT.0000000000002036. Epub 2023 Apr 5.
- Individual participant dataSharing planned: No. Data will only be released as a summary of the results found at each center and overall. No individual patient data will be released.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Zuckermann, MD principal investigator
ALLGEMEINES KRANKENHAUS WIEN
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Heart Failure, run by Paragonix Technologies at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Austria, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Primary Graft Dysfunction (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141605, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.