EVAHEART LVAS Bridge-to-Transplant Pivotal Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Evaheart, Inc.
Sponsor:
Information provided by (Responsible Party):
Evaheart, Inc.
ClinicalTrials.gov Identifier:
NCT01187368
First received: August 19, 2010
Last updated: May 20, 2014
Last verified: May 2014

August 19, 2010
May 20, 2014
July 2010
June 2015   (final data collection date for primary outcome measure)
Survival [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01187368 on ClinicalTrials.gov Archive Site
  • Change in 6-minute walk test [ Time Frame: Baseline versus POD 30, 90, 180, 360 and every 180 days ] [ Designated as safety issue: No ]
  • Change in KCCQ and EuroQol [ Time Frame: Baseline versus POD 30, 90, 180, 360 and every 180 days ] [ Designated as safety issue: No ]
  • Change in neurocognitive function [ Time Frame: Baseline/POD 30 versus POD 90, 180, and 360 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

    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).

  • 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) ] [ Designated as safety issue: Yes ]
  • Survival to transplant [ Time Frame: Implant through transplant, up to 360 days (approximate) ] [ Designated as safety issue: Yes ]
  • NYHA functional class [ Time Frame: Baseline versus POD 30, 90, 180, 360, and every 180 days ] [ Designated as safety issue: No ]
  • Post-transplant or post-explant survival [ Time Frame: 60 days and 1 year post-transplant or post-explant ] [ Designated as safety issue: Yes ]
  • Change in 6-minute walk test [ Time Frame: Baseline versus Months 1, and 6 ] [ Designated as safety issue: No ]
  • Change in KCCQ and EuroQol [ Time Frame: Baseline versus Months 1, 3, 6, 12, and yearly ] [ Designated as safety issue: No ]
  • Change in neurocognitive function [ Time Frame: Baseline/month 1 versus months 3, 6, 12 and yearly ] [ Designated as safety issue: Yes ]
  • Incidence of 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 1 year (approximate) ] [ Designated as safety issue: Yes ]

    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 occcurring during the extension phase (frequency, severity, duration, sequelae and relationship to device).

  • 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 1 year (approximate) ] [ Designated as safety issue: Yes ]
  • Survival to transplant [ Time Frame: Implant through transplant, up to 1 year (approximate) ] [ Designated as safety issue: Yes ]
  • NYHA functional class [ Time Frame: Baseline versus months 1, 3, 6,12, and yearly ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
EVAHEART LVAS Bridge-to-Transplant Pivotal Study
A Prospective Study to Evaluate the Safety and Efficacy of the EVAHEART LVAS for Use as a Bridge-to-Transplant

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2016
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01187368
020-1601-001-P01
Yes
Evaheart, Inc.
Evaheart, Inc.
Not Provided
Principal Investigator: William L Holman, MD University of Alabama at Birmingham
Evaheart, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP