Clinical trial NCT00490321: VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
Official title: Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy
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: 2007-06-22
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant.

This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.

Detailed description: Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.

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

* Eligible for either the VentrAssist or an FDA-approved DT LVAD
* LVEF \<=25%
* Stage D heart failure
* Ineligible for cardiac transplantation
* Treated with standard heart failure therapy

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

* Contraindication to LVAD implantation
* Contraindication to anticoagulant or anti-platelet agents.
* Pre-existing mechanical circulatory support other than intra-aortic balloon pump
* Therapy with an investigational intervention at the time of screening
* A condition, other than heart failure, which would limit survival to less than 2 years

Primary outcomes:
measure: Module A: Survival without a disabling stroke.
measure: Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support.
Secondary outcomes:
measure: •Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment
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: 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
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: 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: University of Pittsburgh Medical Center
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: