VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy

Sponsor

Ventracor (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00490321

Collaborator

International Center for Health Outcomes and Innovation Research (Other)

225

Enrollment

Locations

Duration (Months)

8.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End-stage Heart Failure Cardiomyopathies	Device: VentrAssistTM Left Ventricular Assist Device	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy

Study Start Date :

Jun 1, 2007

Anticipated Study Completion Date :

Jun 1, 2012

Outcome Measures

Primary Outcome Measures

Module A: Survival without a disabling stroke. []
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 Outcome Measures

•Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	Mayo Clinic	Phoenix	Arizona	United States	85054
3	University of Florida	Gainesville	Florida	United States	32610
4	Jackson Memorial	Miami	Florida	United States
5	Northwestern University	Chicago	Illinois	United States	60611
6	St. Vincent's	Indianapolis	Indiana	United States	46260
7	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
8	University of Minnesota	Minneapolis	Minnesota	United States	55455
9	Mayo Clinic	Rochester	Minnesota	United States	55904
10	Washington University School of Medicine	St. Louis	Missouri	United States	63110
11	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
12	Montefiore Medical Center	Bronx	New York	United States	10467
13	Mount Sinai Hospital	New York	New York	United States	10029
14	Columbia University	New York	New York	United States	10032
15	Rochester Medical Center University	Rochester	New York	United States	14642
16	Duke Medical Center	Durham	North Carolina	United States	27710
17	Ohio State University	Columbus	Ohio	United States	43210
18	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
19	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
20	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
21	Methodist Hospital	Houston	Texas	United States	77030
22	University of Utah	Salt Lake City	Utah	United States	84132
23	Fairfax (Inova) Hospital	Falls Church	Virginia	United States	22042
24	University of Washington	Seattle	Washington	United States	98185
25	Sacred Heart Medical Center	Spokane	Washington	United States	99204
26	University of Wisconsin Hospital	Madison	Wisconsin	United States	53792
27	St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215