NCT06035991

Brief Summary

The main objective of PEGASE is to validate the recovery of a satisfactory cardiac function of a transplanted heart after a prolonged period of preservation by an ex-vivo perfusion device. This recovery of cardiac function will have to happen within 15 days after transplantation.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
30mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Oct 2023Oct 2028

First Submitted

Initial submission to the registry

July 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 28, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

July 24, 2023

Last Update Submit

March 18, 2026

Conditions

Heart Transplantation

Keywords

Heart transplantationXVIVO perfusion

Outcome Measures

Primary Outcomes (1)

  • Short term recovery of Cardiac function

    Cardiac index greater than 2.5 L/min/m2 without inotropic support and/or temporary circulatory assistance (ECMO, IMPELLA, BCPIA) measured by thermodilution (SWAN-GANZ catheter) or echocardiography

    Within 15 days after transplantation

Secondary Outcomes (5)

  • Survival

    15 days, 30 days, 9 months, 6 months and 12 months

  • Absence of cardiac deaths

    15 days, 30 days, 3 months, 6 months and 12 months

  • Cardiac function recovery

    30 days, 3months, 6 months and 12 months

  • Adverse events after transplant

    15 days and 12 months

  • Myocardial preservation

    during the procedure/surgery

Study Arms (1)

Patients with end-stage Heart Failure

EXPERIMENTAL
Procedure: Heart transplantation

Interventions

Heart transplantationPROCEDURE

Heart transplantation in patients who have obtained a favourable and motivated opinion from the Multidisciplinary Consultation Meeting (RCP) of the cardiac surgery department of the Hospital Pitié-Salpêtrière

Patients with end-stage Heart Failure

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age
  • Patients suffering from irreversible terminal heart failure with a medical indication for heart transplantation but who cannot be transplanted (per the graft allocation policy in France) or assisted (technical impossibility, contraindication, patient's refusal) and for whom a favourable and motivated opinion from the Multidisciplinary Consultation Meeting (RCP) of the cardiac surgery department of the Hospital Pitié-Salpêtrière has been made
  • Having given their informed consent in writing

You may not qualify if:

  • Technical obstacles which would generate an excessive surgical risk for the patient according to the medical opinion such as comorbidities or associated pathology not compatible with a transplant
  • Known ongoing sepsis, defined as positive blood culture immediately prior to transplant (including with ventricular assist device)
  • Candidate patient for Combined Organ Transplantation
  • Patient protected by law (guardianship, curatorship, deprived of liberty)
  • No affiliated with or entitled to a French social security scheme (AME included)
  • Pregnant or breast-feeding female
  • Patient unable to understand the information provided during the informed consent procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Interventions

Heart Transplantation

Intervention Hierarchy (Ancestors)

Cardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical ProceduresOrgan TransplantationTransplantation

Study Officials

  • Guillaume LEBRETON, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2023

First Posted

September 13, 2023

Study Start

October 28, 2023

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Data are available upon reasonable request. The procedures carried out with the French data regulatory authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not allow for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access Criteria
Researchers who provide a methodologically sound proposal

Locations

FR(1)