Evaluation of the Safety and Effectiveness of the DuraHea... | NCT00710567

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient enrollment

Expanded Access Info

Start Date

Jul 2008Actual

Primary Completion Date

Jan 31, 2012Actual

Completion Date

Nov 12, 2018Actual

First Submitted Date

Jul 2, 2008

First Submission Date that Met QC Criteria

Jul 2, 2008

First Posted Date

Jul 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 19, 2019

Certification/Extension First Submitted that Passed QC Review

Dec 11, 2019

Certification/Extension First Posted Date

Dec 13, 2019Actual

Last Update Submitted Date

Dec 11, 2019

Last Update Posted Date

Dec 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
DuraHeart Left Ventricular Assist System (LVAS)	Device	The DuraHeart LVAS is implanted in using open heart surgery	Historical Data

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama		Birmingham	Alabama	35294	United States
Mayo Clinic - Phoenix

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases