Clinical trial NCT00483197: VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
Official title: Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: End-stage Heart Failure
Cardiomyopathies
Keywords: VentrAssistTM
LVAD
End-stage heart failure
Cardiomyopathy
Lead sponsor: Ventracor
Sponsor class: INDUSTRY
Collaborators: name: International Center for Health Outcomes and Innovation Research
First posted: 2007-06-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.

Detailed description: LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation. The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants.

The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.

Eligibility criteria: Inclusion Criteria:(The following are general criteria; more specific criteria are included in the study protocol):

* Approved and listed for cardiac transplantation.
* Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.

Exclusion Criteria:(The following are general criteria; more specific criteria are included in the study protocol):

* Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function.
* Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents.
* Presence of any mechanical circulatory support other than intra-aortic balloon pump.
* Therapy with an investigational intervention at the time of screening.

Primary outcomes:
measure: Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
Secondary outcomes:
measure: Quality of life
measure: Functional status
measure: Neurocognitive function
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Jackson Memorial
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent's
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: Rochester Medical Center University
state: New York
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Falls Church
country: United States
facility: Fairfax (Inova) Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
References: