Heart Failure
Conditions
Keywords
Heart failure, percutaneous, interventional cardiology, apical remodeling, LV dilatation, akinesis, dyskinesis
Brief summary
The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it is hypothesized that the left ventricle will pump more effectively.
Interventions
DEVICEVPD Implant System
Percutaneous introduction using standard catheterization techniques of the VPD Implant.
Sponsors
CardioKinetix, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region 2. Diagnosis of heart failure for a minimum of 6 months prior to enrollment 3. NYHA Class at time of enrollment, either: * NYHA Class III or IV - if predominant during the 3-month period prior to enrollment * NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment and ≥ 1 hospitalization for heart failure during 12-month period prior to enrollment 4. LVEF ≤ 40% as measured by echocardiography 5. Left ventricle must have appropriate anatomy as measured by Cardiac CT per the VPD Implant sizing criteria described in the device's Instructions For Use 6. Eligible for cardiac surgery 7. Between 18 and 74 years of age (inclusive) 8. Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment 9. Female patients with childbearing potential must have a negative pregnancy test (within 7 days of the procedure) and must agree not to attempt to become pregnant during the course of the study 10. Provide written informed consent 11. Agree to the protocol-required follow-up
Exclusion criteria
1. Myocardial ischemia requiring PCI or CABG 2. Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment 3. Cardiogenic shock within 72 hours of enrollment 4. Revascularization procedure (PCI or CABG) within 60 days of enrollment 5. Patient has received a CRT device within 60 days of enrollment 6. Patient diagnosed with significant valve disease (AI \>1+; MR \>2+) which may or may not require surgery 7. Patient has received an ICD within 60 days of enrollment 8. Patient has received a pacemaker within 60 days of enrollment 9. History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF 10. Patients with a history or a current diagnosis of either persistent or paroxysmal atrial fibrillation as well as patients who present with a contraindication to oral anticoagulant therapy 11. Aortic valve replacement or repair 12. Resting systolic blood pressure is more than 180 mmHg or less than 90 mmHg 13. Resting heart rate more than 120 bpm 14. Cardiac CT or echocardiographic evidence of thrombus in the left ventricle or left atrium 15. History of bleeding diathesis or a major coagulopathy (i.e. platelet count \< 100,000 plts/ml whole blood; PTT or PT \> 1.3 times control value) 16. GI bleed requiring transfusion within the past 3 months 17. Patient has suffered a stroke within the past 6 months 18. Evidence of severe calcification in the VPD Implant attachment zone 19. Evidence of a significant sub-aortic obstruction (left moderator band) in the area of implant 20. History of Kawasaki's disease 21. Patient has received a heart, lung, liver and/or kidney transplant 22. Patient on dialysis or expected to require hemodialysis within 12 months 23. Patient has chronic liver disease 24. Patient has received intracardiac gene therapy or stem cell therapy 25. Creatinine \> 2.5mg/dl or impaired renal function that places patient at risk of contrast induced renal failure 26. Hypersensitivity to contrast media 27. Allergy or contraindication to clopidogrel or aspirin 28. Evidence of ongoing infection (fever with temperature \> 38°C and/or WBC \> 15,000) 29. Co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.) 30. Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety defined as the successful delivery and deployment of the VPD Implant through 6 month follow up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary Effectiveness Measurements at 6 months - Change in LV volume indices (LVESVI, LVEDVI, EF) - Change in 6 minute walk and VO2 max - Cardiovascular mortality and morbidity inclusive of hospitalization for HF, MI and stroke | 12 months |
Countries
Serbia, United States
Outcome results
None listed