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Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

NCT00710567 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-12-13

No results posted yet for this study

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

Interventions

DEVICE

DuraHeart Left Ventricular Assist System (LVAS)

The DuraHeart LVAS is implanted in using open heart surgery

Sponsors & Collaborators

  • Terumo Heart Inc.

    lead INDUSTRY

Principal Investigators

  • Francis D. Pagani, M.D., Ph.D. · University of Michigan

  • Yoshifumi Naka, M.D., Ph.D. · Columbia University

  • David S Feldman, MD · Minneapolis Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-01-31
Completion
2018-11-12

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00710567 on ClinicalTrials.gov