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EVAHEART LVAS Bridge-to-Transplant Pivotal Study

This study is currently recruiting participants.
Verified May 2013 by Evaheart Medical USA, Inc.
Sponsor:
Information provided by (Responsible Party):
Evaheart Medical USA, Inc.
ClinicalTrials.gov Identifier:
NCT01187368
First received: August 19, 2010
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Heart Failure
 Device: EVAHEART Left Ventricular Assist System (LVAS)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Evaheart Medical USA, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The following is a list of general inclusion criteria; more detailed information is noted in the study protocol:

  • 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

Exclusion Criteria:

The following is a list of general exclusion criteria; more detailed information is noted in the study protocol:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christyna Zalewski, BSN, RN     215-662-4290     christyna.zalewski@uphs.upenn.edu    
Principal Investigator: Y. Joseph Woo, MD            
Principal Investigator: J. Eduardo Rame, MD            
University of Pittsburgh Medical Center Withdrawn
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
The Methodist Hospital Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Raquel Bunge, RN, CCRC     713-441-6509     rrbunge2@tmhs.org    
Principal Investigator: Brian Bruckner, MD            
Sub-Investigator: Matthias Loebe, MD, PhD            
Sponsors and Collaborators
Evaheart Medical USA, Inc.
Investigators
Principal Investigator: William L Holman, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Evaheart Medical USA, Inc.
ClinicalTrials.gov Identifier: NCT01187368     History of Changes
Other Study ID Numbers: 020-1601-001-P01
Study First Received: August 19, 2010
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013