The primary objective is to continue to assess the long term safety of the CardioKinetix Parachute Implant System in the partitioning of the leftventricle in patients 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 long term safety as measured by site-reported procedural and
device related MACE in real world use of the Parachute Implant through 5 years
of clinical follow-up
Secondary outcome
Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End
Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months, and
annually through 5 years.
Change in exercise tolerance from baseline to 6 and 12 month follow-up as
measured by 6-Minute Walk Test.
Number of and time to the combined cardiovascular mortality and morbidity that
includes all cause death, hospitalization for heart failure, myocardial
infarction, and stroke, whichever is earlier, within 6, and 12 months from the
date of implantation of the study device
Background summary
In regard to the current available therapies for heart failure, 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.
Background described in Chapter 1 of the protocol.
Study objective
The primary objective is to continue to assess the long term safety of the
CardioKinetix Parachute Implant System in the partitioning of the left
ventricle in patients with heart failure due to ischemic heart disease.
Study design
Prospective, multi-center, post-market, non-randomized, observational study of
the CE marked CardioKinetix Parachute Implant System
Intervention
Implantation of the CardioKinetics Parachute Device. Implantation occurs
through heart catheterization through the arteria femorali.s
Device described in Chapter 5.4 of the protocol
Study burden and risks
Hyptotension or hypertension
Endocarditis of the Device
Peripheral embolism/thrombus
Cardiac tamponade
Emergent or urgent cardiac surgery
Hamilton Avenue 925
Menlo Park 94025
US
Hamilton Avenue 925
Menlo Park 94025
US
Listed location countries
Age
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:
NYHA Class III or Ambulatory 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
* LVEF >15% and* 40% as measured by echocardiography.
* Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by
echocardiography.
* 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
Exclusion criteria
* Untreated clinically significant coronary artery disease requiring intervention.
* Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
* Cardiogenic shock within 72 hours of enrollment
* Revascularization procedure (PCI or CABG) within 60 days of enrollment
* Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment
* History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
* Aortic valve replacement or repair
* Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
* Active peptic ulcer or GI bleeding within the past 3 months
* Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within
the past 6 months
* History of Kawasaki*s disease
* Ongoing sepsis, including active endocarditis.
* Anatomical characteristics not suitable for treatment with the Parachute Implant device as
screened by the echocardiography core lab. (characteristics include inappropriate size and shape
of the left ventricle, presence of LV apical thrombus, pseudo chordae or trabeculations)
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 | NL40775.041.12 |