Heart Failure, Left Ventricular Dysfunction
Conditions
Keywords
heart failure, parachute, partitioning device
Brief summary
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.
Detailed description
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the European Conformity Approved (CE marked) CardioKinetix Parachute Implant System. The primary objective is to establish quality-of-life and cardiac output benefit of the Parachute Implant of patients presenting with symptoms of heart failure due to ischemic heart disease. A maximum of 105 treated patients and approximately 25 control patients may be enrolled, with a maximum of 25 treated patients enrolled from any one center. The Primary Endpoint is an improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline using the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The Secondary Endpoint is an improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.
Interventions
DEVICEParachute Implant System
The CardioKinetix Parachute Implant partitions an enlarged ventricle into dynamic and static chambers. The static chamber is a portion of the left ventricular volume that is taken out of circulation. Stresses placed on the partitioned myocardium and the forces transmitted to the apical segment are decreased both in diastole and systole, eliminating the forces responsible for left ventricular dilation. In addition to this regional unloading, the reduction in size of the dynamic chamber results in a decrease of the myocardial stress in the normal myocardium via Laplace Law, providing a global unloading of the ventricle.
Sponsors
CardioKinetix, Inc
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post MI structural heart dysfunction represented by left ventricular (LV) wall motion abnormality (WMA) * Symptomatic Heart Failure with reduced Ejection Fraction (EF) (≤ 40%) * Receiving stable medication for heart failure according to the European Society of Cardiology (ESC) Heart Failure (HF) Guidelines * \>18 years of age * Provide written informed consent * Agree to the protocol-required follow-up
Exclusion criteria
* Acute myocardial infarction (MI) of the left anterior descending territory within 90 days of enrollment or patients with suspected evolving MI at time of enrollment * Cardiogenic shock within 72 hours of enrollment * A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated * Other hemodynamically structural heart interventions or heart failure device treatment at time of Parachute implant, e.g. mitral valve clip or cardiac resynchronization therapy). * Co-morbidities associated with a life expectancy of less than 12-months * Treatment Arm only (Control Arm excluded from this criteria): Anatomical characteristics not suitable for treatment with the Parachute Implant device as screened by magnetic resonance imaging (MRI) or computerized tomography (CT). (Characteristics include inappropriate size and shape of the left ventricle, pseudo chordae or trabeculations interfering with device placement.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 6 months | An improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline (day -1) using the Minnesota Living with Heart Failure (MLWHF) Questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Volume Index | 0 days (at implant) | An improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure. |
Countries
Germany
Outcome results
None listed