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EVAHEART LVAS Bridge-to-Transplant Pivotal Study

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ClinicalTrials.gov Identifier: NCT01187368
Recruitment Status : Recruiting
First Posted : August 24, 2010
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Evaheart, Inc.

Brief Summary:
The objective of this pivotal study is to assess the safety and efficacy of the EVAHEART LVAS as a bridge-to-transplant for subjects with end stage heart failure. Subjects will be followed for 180 days after the EVAHEART LVAS implant or until cardiac transplant or explant for recovery (+ 60 days or discharge). If after 180 days post-implant the subject has not received a cardiac transplant or the device has not been explanted, the subject will continue to be followed monthly.

Condition or disease Intervention/treatment Phase
Heart Failure Device: EVAHEART Left Ventricular Assist System (LVAS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Safety and Efficacy of the EVAHEART LVAS for Use as a Bridge-to-Transplant
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Bridge to Transplant
Bridge to Transplant
Device: EVAHEART Left Ventricular Assist System (LVAS)
continuous flow implantable left ventricular assist system (LVAS) for patients who are at risk of imminent death from severe left ventricular failure for use as a bridge-to-transplantation in candidates listed for cardiac transplant
Other Name: EVAHEART LVAS



Primary Outcome Measures :
  1. Survival [ Time Frame: 180 days ]
    Survival to cardiac transplant or device explant for recovery (+ 60 days or discharge) or survival to 180 days after implantation of the originally implanted device


Secondary Outcome Measures :
  1. Change in 6-minute walk test [ Time Frame: Baseline versus POD 30, 90, 180, 360 and every 180 days ]
  2. Change in KCCQ and EuroQol [ Time Frame: Baseline versus POD 30, 90, 180, 360 and every 180 days ]
  3. Change in neurocognitive function [ Time Frame: Baseline/POD 30 versus POD 90, 180, and 360 ]
  4. Incidence of adverse events, serious adverse events and UADEs [ Time Frame: Implant through transplant or explant for recovery (+60 days or discharge) or 180 days on device; then duration of device support, up to 360 days (approximate) ]

    Peri-operative complications and any failure to successfully implant the device.

    All adverse events occurring during the acute and chronic phase of the study (frequency, severity, duration, sequelae and relationship to device).

    All adverse events occurring during the extension phase (frequency, severity, duration, sequelae and relationship to device).


  5. Incidence of all device failures and device malfunctions [ Time Frame: Implant through transplant or explant for recovery (+60 days or discharge) or 180 days on device; then duration of device support, up to 360 days(approximate) ]
  6. Survival to transplant [ Time Frame: Implant through transplant, up to 360 days (approximate) ]
  7. NYHA functional class [ Time Frame: Baseline versus POD 30, 90, 180, 360, and every 180 days ]
  8. Post-transplant or post-explant survival [ Time Frame: 60 days and 1 year post-transplant or post-explant ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The following is a list of general inclusion criteria:

  • Age ≥ 18 years
  • Listed for cardiac transplant as a status 1A or 1B
  • NYHA Class IV heart failure
  • Patient is able to provide written informed consent
  • More detailed inclusion criteria information is noted in the study protocol

Exclusion Criteria:

The following is a list of general exclusion criteria:

  • Active, uncontrolled infection
  • BSA < 1.4 m²
  • Irreversible organ failure
  • Severe right ventricular failure
  • Prosthetic mechanical aortic or mitral valve
  • Patients with an unacceptable risk for successful LVAD implantation and maintenance
  • Patients refusing blood transfusion
  • Intolerant of anticoagulation therapy
  • Coagulopathy
  • Active psychiatric disorder, irreversible cognitive dysfunction or other psychosocial behavior that impairs the ability of the patient to follow instructions, maintain their device or their medical regimen
  • Pregnancy
  • Current dependence on other mechanical circulatory support device at the time of implant, other than IABP
  • Presence of condition other than heart failure that would limit survival to less than 3 years
  • More detailed exclusion criteria information is noted in the study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187368


Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: David Baldwin    205-975-8519    transres@cardiology.uab.edu   
Contact: Gina Horton, RN    205-975-8519    transres@cardiology.uab.edu   
Principal Investigator: Salpy V Pamboukian, MD, MSPH         
United States, Texas
Texas Heart Institute Not yet recruiting
Houston, Texas, United States, 77030
Contact: Felicia Trent, MBA    832-355-9007    ftrent@texasheart.org   
Principal Investigator: William Cohn, MD         
Sponsors and Collaborators
Evaheart, Inc.
Investigators
Principal Investigator: William L Holman, MD University of Alabama at Birmingham

Responsible Party: Evaheart, Inc.
ClinicalTrials.gov Identifier: NCT01187368     History of Changes
Other Study ID Numbers: 020-1601-001-P01
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Evaheart, Inc.:
heart failure
LVAS
LVAD
bridge-to-transplant
rotary pump

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases