Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPD Implant System | Device | Percutaneous introduction using standard catheterization techniques of the VPD Implant. |
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
Diagnosis of heart failure for a minimum of 6 months prior to enrollment
NYHA Class at time of enrollment, either:
LVEF ≤ 40% as measured by echocardiography
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
Eligible for cardiac surgery
Between 18 and 74 years of age (inclusive)
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
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
Provide written informed consent
Agree to the protocol-required follow-up
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William T Abraham, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Northwestern University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25037310 | Derived | Costa MA, Mazzaferri EL Jr, Sievert H, Abraham WT. Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure: three-year outcomes of the PARACHUTE first-in-human study. Circ Heart Fail. 2014 Sep;7(5):752-8. doi: 10.1161/CIRCHEARTFAILURE.114.001127. Epub 2014 Jul 18. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Chicago |
| Illinois |
| 60611 |
| United States |
| Mission Hospitals | Asheville | North Carolina | 28802 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| Dedinje Cardiovascular Institute | Belgrade | 11040 | Serbia |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |