The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle inpatients with heart failure due to ischemic heart disease.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End
Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months.
Change in exercise tolerance from baseline to 6 and 12 month follow-up as
measured by 6-Minute Walk Test.
Combined cardiovascular mortality and morbidity that includes all cause death,
hospitalization for heart failure, myocardial infarction and stroke from
baseline to 6, and 12 months.
Background summary
There are a number of treatment options available to minimize symptoms of
heartfailure and somewhat slow disease progression. The combination of
lifestyle changes and drug therapy*the foundation of almost all HF treatment
regimens*can improve both survival rates and quality of life and is most often
initiated in NYHA Class I and Class II patients. Each class of heart failure
may warrant a different combination of medications. If drug therapy does not
adequately enhance LV function, patients with advanced heart failure may become
candidates for other interventions, including surgery and implantable devices.
While the above therapies 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, a catheter-based
treatment for patients with heart failure due to ischemic heart disease (left
ventricular dilation after an anterior MI) has been developed. The implantable
device, called the Parachute, is a partitioning membrane deployed within the
compromised ventricle. The Parachute isolates the dysfunctional region of the
ventricle and decreases chamber volume.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 objective
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.
Study design
The study is designed as a prospective, multi-center, non-randomized, dual arm,
observational study of the CardioKinetix Parachute Implant and Delivery System.
Intervention
Percutaneous implantation of a Parachute in the left ventricle in patients with
chronic heart faillure and due to ischemic heart dissease.
Study burden and risks
The risks associated with the implantation of the Parachute are expected not to
be significantly different than cardiac catheterization and interventional
procedures.
Clinical follow up at 6 months and 1,2,3,4 and 5 years post procedure. During
the follow up at 6 and 12 months the patients will perform a 6 minute walk test
and during the 6 month follow up there will be taken a chest X-ray.
The patients may benefit from participating in this study, because there may be
improvement of hemodynamics and heart faillure symptoms after implantation of
the Parachute.
925 Hamilton Ave
Menlo Park, CA 94025
US
925 Hamilton Ave
Menlo Park, CA 94025
US
Listed location countries
Age
Inclusion criteria
Akinesis or dyskinesis due to previous myocardial infarction limited to anteroapical region.
Patient is not hospitalized at time of enrollment.
Diagnosis of heart failure for a minimum of 6 months prior to enrollment
NYHA Class III or IV .
Post LV myocardial infarction structural heart dysfunction represented by LV wall motion abnormality by echocardiography.
LVEF >15% and * 40% as measured by echocardiography.
Between 18 and 79 years of age.
Receiving appropriate medical treatment for heart failure.
Exclusion criteria
Untreated clinically significant coronary artery disease requiring intervention.
Acute myocardial infarction or revascularization procedure (PCI or CABG) within 60 days of enrollment.
Cardiogenic shock within 72 hours of enrollment.
Contraindication for asparin and anticoagulation therapy.
Moderate aortic stenosis and regurgitation >2+.
Aortic valve replacement or repair.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35125.018.11 |