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| Sponsor: | World Heart Corporation |
|---|---|
| Information provided by (Responsible Party): | World Heart Corporation |
| ClinicalTrials.gov Identifier: | NCT01001793 |
Purpose
The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with presumed non-reversible left ventricular failure.
| Condition | Intervention |
|---|---|
|
Refractory Heart Failure |
Device: Levacor Ventricular Assist Device |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Levacor™ Ventricular Assist Device as a Bridge to Cardiac Transplantation |
| Enrollment: | 15 |
| Study Start Date: | August 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| United States, Kentucky | |
| Jewish Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Oklahoma | |
| INTEGRIS Baptist Medical Center | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Utah | |
| University of Utah Hospital | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Inova Fairfax Hospital/Inova Heart & Vascular Institute | |
| Falls Church, Virginia, United States, 22042 | |
More Information
| Responsible Party: | World Heart Corporation |
| ClinicalTrials.gov Identifier: | NCT01001793 History of Changes |
| Other Study ID Numbers: | LEV01 |
| Study First Received: | October 24, 2009 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Heart Failure Heart Diseases Cardiovascular Diseases |