NCT00855712

Brief Summary

The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable heart-failure

Geographic Reach
4 countries

11 active sites

Status
completed

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 Start

First participant enrolled

March 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 9, 2020

Status Verified

May 1, 2015

Enrollment Period

4.6 years

First QC Date

March 3, 2009

Last Update Submit

June 4, 2020

Conditions

Heart Failure

Keywords

Heart FailureTransplantWarm PerfusionOrgan CareResting Mode

Outcome Measures

Primary Outcomes (1)

  • 30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30

    30 days

Secondary Outcomes (3)

  • Incidence of all cardiac graft-related serious adverse events

    30 days

  • Incidence of biopsy proven ISHLT grade 2R or 3R acute rejection on any of the surveillance endomyocardial biopsies or clinically symptomatic rejection requiring augmentation of immunosuppressive therapy during the 30 day follow up

    30 day

  • Length of ICU stay

    30 day

Study Arms (2)

Organ Care System

EXPERIMENTAL
Device: Organ Care System

Cold cardioplegia solution

ACTIVE COMPARATOR
Device: Cold Cardioplegia Solution

Interventions

Organ Care SystemDEVICE

The Organ Care System (OCS) is a portable organ perfusion and monitoring system intended to preserve a donated heart in a near normal physiologic beating state during transport for eventual transplantation into a recipient. The OCS maintains organ viability by providing a controlled environment that simulates near-normal physiological conditions, continuously perfusing the donated heart with warm, oxygenated blood, supplemented with the Solution Set. The blood is collected from the donor and continuously circulated to the organ in a closed circuit along with the Solution. The OCS preserves and monitors the organ's perfusion and metabolic state after explantation from a donor and connection to the device, during transportation to the recipient site, and until disconnection from the device.

Also known as: OCS
Organ Care System
Cold Cardioplegia SolutionDEVICE

This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital

Cold cardioplegia solution

Eligibility Criteria

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

You may qualify if:

  • Recipient Day of Transplant
  • Registered male or female primary heart transplant candidate
  • ≥18 years old
  • Signed, written informed consent document and authorization to use and disclose protected health information
  • Donor Hearts
  • \<60 years old
  • Mean systolic blood pressure \>60 mmHg at the time of final heart assessment
  • Satisfactory echocardiography assessment defined as:
  • Ejection fraction \>40%
  • Absence of severe segmental wall motion abnormalities
  • Absence of left ventricular hypertrophy (inter ventricular septum and posterior wall thickness \<1.3 cm)
  • Absence of valve abnormalities (trace to mild valvular regurgitation is acceptable)

You may not qualify if:

  • Recipient Day of Transplant
  • \>4 previous sternotomies
  • Chronic renal failure as defined by chronic serum creatinine \>3.0 mg/dL for more than 2 weeks and/or requiring hemodialysis (except for hemodialysis or hemofiltration for fluid overload)
  • Ventilator dependence at the time of transplant
  • Use of a ventricular assist device for \> 30 days and the presence of any of the following: sepsis, intracranial hemorrhage or heparin induced thrombocytopenia
  • Panel reactive antibodies \> 40% with a positive prospective cross match and/or virtual cross match
  • Use of an investigational drug or device, other than OCS, during the study.
  • Simultaneous transplant of non-heart allograft, except for concurrent kidney transplant
  • Donor Hearts
  • Abnormal coronary angiogram defined as \>50% stenosis, requiring coronary bypass
  • Donor-to-recipient body weight ratio of \<0.6
  • Inotrope support at time of final heart assessment including, but not limited to:
  • Dopamine \>10 ug/kg/min
  • Dobutamine \> 10 ug/kg/min
  • Milrinone \>0.3 ug/kg/min
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90211, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Azienda Ospedaliera S. Maria della Misericordia

Udine, 33100, Italy

Location

Papworth Hospital

Cambridge, CB23 3RE, United Kingdom

Location

Harefield Hospital

London, United Kingdom

Location

Related Publications (1)

  • Ardehali A, Esmailian F, Deng M, Soltesz E, Hsich E, Naka Y, Mancini D, Camacho M, Zucker M, Leprince P, Padera R, Kobashigawa J; PROCEED II trial investigators. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet. 2015 Jun 27;385(9987):2577-84. doi: 10.1016/S0140-6736(15)60261-6. Epub 2015 Apr 14.

    PMID: 25888086DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Abbas Ardehali, MD

    University of California, Los Angeles

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

June 9, 2020

Record last verified: 2015-05

Locations

FR(1)US(7)IT(1)GB(2)