The primary objective is to assess the 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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Mechanical ventricular partitioning
Hospital of Cardiology Louis Pradel (Lyon)
Bron, France
Institut Cardiovasculaire Paris-Sud
Massy, France
University of Heidelberg
Heidelberg, Germany
The successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE)
Assessment of safety defined as the successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device.
Time frame: 6-months
Change in Left Ventricular Volume Indexes.
Change in Left Ventricular Volume Indexes including End Systolic {LVESVI} and End Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months
Time frame: 6 months
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Universitat Rostock
Rostock, Germany
Pauls Stradins Clinical University Hospital
Riga, Latvia
University of Amsterdam AMC
Amsterdam, Netherlands
Hospital Santa Marta
Lisbon, Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, Portugal
Clinical Center of Serbia (KCS)
Belgrade, Serbia
Ljubljana University Medical Center (Univerzitetni Klinicni Center Ljubljana)
Ljubljana, Slovenia
...and 3 more locations