Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

Not Applicable

Terminated

• Conditions: Heart Failure

• Registration Number: NCT00710567
• Lead Sponsor: Terumo Heart Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-04
• Primary Completion: 2012-01-31
• Study Completion: 2018-11-12
• Status Verified: 2019-03
• Disposition First Submitted: 2019-09-19
• Disposition First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Disposition First Posted: 2019-12-13
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (26)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic - Phoenix; 🇺🇸 Phoenix, Arizona, United States

University of Arizona Medical Center; 🇺🇸 Tucson, Arizona, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

St. Joseph's Hospital of Atlanta; 🇺🇸 Atlanta, Georgia, United States

St. Vincent Hospital; 🇺🇸 Indianapolis, Indiana, United States

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