heart failure reduced pump function of the heart.
Conditions
Interventions
Patients randomized to the Investigational Device group will be admitted to the
hospital within 7 and 10 days after randomization to undergo the
cardio-thoracic surgical procedure employing a limite
Sponsors
LoneStar Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The patients must be able and willing to give written informed consent; 2. The patients will be adult (age >= 18 years and
Exclusion criteria
Exclusion criteria: 1. Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD within the next 6 months; 2. Patients presenting with cardiogenic shock; 3. Patients who have undergone a previous mid-sternotomy surgical procedure are excluded unless the surgeon*s assessment is that the left sided limited thoracotomy is feasible and considered reasonable surgical risk; 4. Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis; 5. Patient with a history of constrictive pericarditis; 6. Patients with a Q wave myocardial infarction (MI) within the last 30 days; 7. Patients with a recent history of stroke (within 60 days prior to the surgical procedure); 8. A left ventricular (LV) wall thickness of the LV free-wall, at the midventricular level, of less than 8 mm (screening echocardiography must confirm a minimum wall thickness of 8 mm); 9. Patients with a serum creatinine > 2.5 mg/dL; 10. Clinically significant liver enzyme abnormalities, i.e., AST(SGOT) and ALT (SGPT) more than 2.5 times the upper limit of normal; 11. History of severe COPD (i.e., FEV 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary safety outcome is to estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device; 2. The primary efficacy outcome is the change in Peak VO2 from baseline to 6 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of major surgical complications (30 days post op); 2. Incidence of major anesthesia-related complications; 3. Incidence of major adverse cardiac event (MACE). MACE is defined as cardiac death, cardiac arrest, myocardial infarction, sustained ventricular arrhythmias, pulmonary edema, acute heart failure, unstable angina and major bleeding (6 months); 4. Overall incidence and freedom from serious adverse events (6 months); 5. All-cause mortality and cardiovascular mortality (6 months); 6. All-cause hospitalizations and heart failure hospitalizations (6 months); 7. Time to first heart failure hospitalization (6 months); 8. Number of days alive out of hospital (all cause) during the 1st 6 months; 9. Laboratory assessments (6 months); 10. Adverse events; 11. Cardiac imaging (Echo and MRI or Nuclear Imaging) measures of changes in left ventricular volume, ejection fraction, dimensions, and mitral regurgitation (6 months); 12. Six-minute walk distance (6 months); 13. Quality of life as measured by KCCQ (6 months); 14. Patient Global Assessment (PGA) (6 months); 15. NYHA Functional Class (6 months). | — |
Countries
Netherlands
Outcome results
None listed