Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

Heart Failure Clinical Trial

Official title:

Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00710567
• Other study ID #: DH003
• Status: Terminated
• Phase: N/A
• Start date: July 2008
• Est. completion date: November 12, 2018

Study information

• Verified date: March 2019
• Source: Terumo Heart Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation.

Study Population The patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. Patients must be listed for transplant with UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.

Study Design This is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur within an 18-month time period at up to 40 centers. All patients will be followed for all endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or death, whichever occurs first. For those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. If patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: November 12, 2018
• Est. primary completion date: January 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The following are general criteria; more specific conditions are included in the study protocol:

1. Approved for cardiac transplantation

2. Listed with UNOS on the Status 1 list

3. Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation

Exclusion Criteria:

The following are general criteria; more specific conditions are included in the study protocol:

1. Contraindication to the administration of warfarin or anti-platelet agents

2. Primary coagulopathy or platelet disorder

3. Acute myocardial infarction within 48 hours prior to enrollment

4. Anticipated need for RVAD support or ECMO at the time of LVAS implantation

5. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• DuraHeart Left Ventricular Assist System (LVAS)
The DuraHeart LVAS is implanted in using open heart surgery

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	St. Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	University of Alabama	Birmingham	Alabama
United States	Medical City	Dallas	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State University	Hershey	Pennsylvania
United States	Methodist Hospital	Houston	Texas
United States	Texas Heart Institute	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	University of Southern California	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Miami	Miami	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Minneapoils Heart Institute Foundation	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Mt. Sinai School of Medicine	New York	New York
United States	Newark Beth Israel	Newark	New Jersey
United States	Temple University	Philadelphia	Pennsylvania
United States	Mayo Clinic - Phoenix	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Heart Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.		180 days