Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study

Refractory Heart Failure Clinical Trial

Official title:

Evaluation of the Levacor™ Ventricular Assist Device as a Bridge to Cardiac Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01001793
• Other study ID #: LEV01
• Status: Terminated
• Phase: N/A
• First received: October 24, 2009
• Last updated: December 22, 2011
• Start date: August 2009
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: World Heart Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must be at least 18 years of age at the time of VAD implantation.

2. Listed for cardiac transplantation as UNOS Status 1A or 1B at the time of VAD implantation or within 72 hours of VAD implantation.

3. Body Surface Area (BSA) 1.2 m2 or greater.

4. If female of childbearing potential must have negative pregnancy test.

5. Patient has signed an Informed Consent.

Exclusion Criteria:

1. Unacceptable surgical risk according to Principal Investigator.

2. Intolerance or contraindication to anticoagulation or antiplatelet therapies.

3. Excessive risk of bleeding as evidenced by INR > 2.3, or PTT > 45 sec, or platelet count < 50,000 U, unresponsive to treatment.

4. Excessive neurologic risk documented as TIA within the last 3 months or stroke within the last 6 months.

5. Evidence of any of the following indicators of end-organ dysfunction: total bilirubin > 4 mg/dL, ALT/AST > 3 times upper limit normal, serum creatinine >3.5 mg/dL.

6. Fixed pulmonary hypertension with a most recent PVR > 5 Wood units unresponsive to pharmacological intervention.

7. Severe chronic obstructive pulmonary disease as evidenced by an FEV1 < 1.0 L or restrictive lung disease or prolonged (> 48 hours) intubation.

8. Presence of mechanical aortic valve that will not be converted to a bioprosthesis during VAD implantation.

9. Planned concomitant surgical procedures other than aortic valve repair or tissue valve placement to treat moderate to severe aortic insufficiency, tricuspid valve repair, mitral valve repair, critical lesion CABG, LV thrombectomy (apical), closure of persistent foramen ovale, atrial septal defect.

10. Cardiogenic shock secondary to acute myocardial infarction.

11. Presence of ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.

12. Presence of uncontrolled infection.

13. BMI > 40 kg/m2.

14. Significant peripheral vascular disease accompanied by pain at rest, extremity ulceration or disabling claudication.

15. Illness, other than heart disease, that would limit survival to less than 1 year.

16. Pulmonary embolus < 2 weeks before VAD implant.

17. Poor/compromising nutritional status in judgment of Principal Investigator.

18. Participation in another clinical trial that, according to the Principal Investigator, is likely to affect the Study outcome or confound the results.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractory Heart Failure

Intervention

Device:
• Levacor Ventricular Assist Device
Surgical procedure

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Inova Fairfax Hospital/Inova Heart & Vascular Institute	Falls Church	Virginia
United States	Jewish Hospital	Louisville	Kentucky
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
World Heart Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success is defined as any one of the following: survival to cardiac transplantation prior to 180 days, survival on device to 180 days, device removal for recovery and survival to 60 days after device removal		6 months	Yes
Secondary	Survival to transplant		6 months	Yes
Secondary	Survival 30 days post-transplant		6 months	Yes
Secondary	Survival while on device		6 months	Yes
Secondary	Incidence of adverse events while on device		6 months	Yes
Secondary	Device reliability		6 months	Yes
Secondary	Reoperations		6 months	Yes
Secondary	Functional status		6 months	Yes
Secondary	Quality of life		6 months	Yes
Secondary	Neurocognitive evaluation		6 months	Yes