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
Not provided
Not provided
The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.
While current therapies for heart failure (including but not limited to: medical management, cardiac resynchronization and ICDs) may represent the best treatment available today for the majority of HF patients, the medical community recognizes that pharmacologic therapy has been optimized to nearly the extent that is possible, and that any incremental improvements in the management of HF patients will now come from device based therapies. With this background, CardioKinetix has developed a catheter-based intravascular approach to ventricular partitioning using an implantable device. The purpose of this study is to assess the longterm safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of the left ventricle in patients with symptoms of HF due to ischemic heart disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of long term safety of the Parachute system | Assessment of long term safety as measured by site-reported device related MACE in real in real-world use of the Parachute Implant through 5 years of clinical follow-up. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Volume Indices | Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) as measured by echocardiography from baseline to 6 months and annually to 5 years | 6 months and annually to 5 years |
Not provided
Inclusion Criteria:
Candidates for this study must meet ALL of the following inclusion criteria:
Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
Subject is not hospitalized at time of enrollment.
NYHA Class at time of enrollment, either:
LVEF >15 or% and ≤ 40% as measured by echocardiography.
Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
Eligible for cardiac surgery
Between 18 and 79 years of age (inclusive)
Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2009 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
Provide written informed consent
Agree to the protocol-required follow-up
Exclusion Criteria:
Candidates will be excluded from the study if ANY of the following conditions apply:
Not provided
Not provided
The study population will be open to all individuals who meet the inclusion/exclusion criteria. This is a prospective, multi-center, non-randomized trial.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Simon Redwood, MD | St. Thomas' Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Hospital Aalst | Aalst | 9300 | Belgium | |||
| ZNA Middelheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26499223 | Derived | Thomas M, Nienaber CA, Ince H, Erglis A, Vukcevic V, Schafer U, Ferreira RC, Hardt S, Verheye S, Gama Ribeiro V, Sugeng L, Tamburino C. Percutaneous ventricular restoration (PVR) therapy using the Parachute device in 100 subjects with ischaemic dilated heart failure: one-year primary endpoint results of PARACHUTE III, a European trial. EuroIntervention. 2015 Oct;11(6):710-7. doi: 10.4244/EIJV11I6A143. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009203 | Myocardial Infarction |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Antwerp |
| 2020 |
| Belgium |
| Kerckhoff-Klinik SGmbh | Bad Nauheim | 61231 | Germany |
| Arzt St. Marien-Hospital Abt. Innere Medizin | Bonn | 53115 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| University of Heidelberg | Heidelberg | 69120 | Germany |
| University Hospital Leipzig | Leipzig | 04289 | Germany |
| Universitat Rostok | Rostock | 18057 | Germany |
| Ferrarotto University Hospital Catania | Catania | 95123 | Italy |
| University Medical Center (UMC) Utrecht | Utrecht | 3508 | Netherlands |
| Hospital Clinico de Barcelona | Barcelona | 08028 | Spain |
| Golden Jubilee Hospital | Glasgow | G81 4DY | United Kingdom |
| St. Thomas' Hospital | London | SE1 7EH | United Kingdom |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |