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TERMINATEDNANCT00710567

Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

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 transpl...

Lead sponsor: Terumo Heart Inc.•25 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Terumo Heart Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 13, 2019Terms

Trial snapshot

StatusTERMINATED

PhaseNA

Enrollment66

Start dateJul 2008

Last updatedDec 13, 2019

Condition

Locations shown

University of Alabama

Birmingham, Alabama

Mayo Clinic - Phoenix

Phoenix, Arizona

University of Arizona Medical Center

Tucson, Arizona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2019Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions