Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

NCT00710567 | Terminated

• 1 other identifier: DH003
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 26

Brief 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.

Conditions

Heart Failure

Keywords

Heart Failure; LVAS; LVAD; Rotary Pump

Outcome Measures

Primary Outcomes (1)

• Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.

  180 days

Study Arms (1)

Historical Data

OTHER

DuraHeart Patients will be implanted with a DuraHeart Left Ventricular Assist System (LVAS) as a "bridge to transplant" until a suitable heart can be found as a replacement. Parameters collected will be compared to a performance goal based on historical data for congestive heart failure patients

Device: DuraHeart Left Ventricular Assist System (LVAS)

Interventions

DuraHeart Left Ventricular Assist System (LVAS) DEVICE

The DuraHeart LVAS is implanted in using open heart surgery

Also known as: LVAD

Historical Data

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The following are general criteria; more specific conditions are included in the study protocol:
• Approved for cardiac transplantation
• Listed with UNOS on the Status 1 list
• Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation

You may not qualify if:

• The following are general criteria; more specific conditions are included in the study protocol:
• Contraindication to the administration of warfarin or anti-platelet agents
• Primary coagulopathy or platelet disorder
• Acute myocardial infarction within 48 hours prior to enrollment
• Anticipated need for RVAD support or ECMO at the time of LVAS implantation
• Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device

Sponsors & Collaborators

• Terumo Heart Inc.: lead

Study Sites (26)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic - Phoenix

Phoenix, Arizona, 85054, United States

Location

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

St. Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46260, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Minneapoils Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Newark Beth Israel

Newark, New Jersey, 07112, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Penn State University

Hershey, Pennsylvania, 17033, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical City

Dallas, Texas, 75230, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Francis D. Pagani, M.D., Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Yoshifumi Naka, M.D., Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

• David S Feldman, MD

  Minneapolis Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: July 1, 2008
• Primary Completion: January 31, 2012
• Study Completion: November 12, 2018
• Last Updated: December 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (25); CA (1)