Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT00710567
Status:
TERMINATED
Last Update Posted:
2019-12-13
First Post:
2008-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
Sponsor:
Terumo Heart Inc.
Organization:
Study Overview
Official Title:
Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: