Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.
The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
| Condition | Intervention |
|---|---|
|
Heart Failure, Congestive Ventricular Dysfunction Cardiomyopathies |
Device: Left Ventricular Assist System (LVAS) |
Thoratec Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy |
- Survival to two (2) years free of: stroke, or reoperation to repair or replace the device [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
- Incidence of adverse events [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
- Clinical reliability (malfunctions/failures) [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
- Functional status [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
- Reoperations [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
- Neurocognitive assessments [ Time Frame: 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Post-transplant survival [ Time Frame: 30 days, 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 260 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HeartMate II
Implantation of HeartMate II LVAS
|
Device: Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
Other Names:
|
|
Active Comparator: HeartMate XVE
Implantation of HeartMate XVE LVAS
|
Device: Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
Other Names:
|
Detailed Description:
The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver.
The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following are general criteria; more specific conditions are included in the study protocol:
Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
- On optimal medical management and are failing to respond; or
- In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
- Treated with ACE inhibitors or beta-blockers and found to be intolerant.
- Ineligible for cardiac transplant
- VO2max <=14 ml/kg/min
- LVEF <=25%
Exclusion Criteria:
The following are general criteria; more specific conditions are included in the study protocol:
- Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
- Existence of factors that would adversely affect patient survival or function of the LVAS
- Intolerance to anticoagulant or antiplatelet therapies.
- Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome
Contacts and Locations
Show 47 Study Locations| Study Director: | Laura Damme | Thoratec Corporation |
More Information
No publications provided by Thoratec Corporation
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Laura Damme, Sr. Director, Clinical Affairs, Thoratec Corporation |
| ClinicalTrials.gov Identifier: | NCT00121485 History of Changes |
| Other Study ID Numbers: | TC010230-2 |
| Study First Received: | July 12, 2005 |
| Last Updated: | January 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Thoratec Corporation:
|
Heart-assist devices |
Additional relevant MeSH terms:
|
Heart Failure Ventricular Dysfunction Cardiomyopathies Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013