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Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group | Subjects who meet the inclusion/exclusion criteria listed and also are approved via anatomical inclusion criteria for treatment with the Parachute Implant System. |
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| Control group | Subjects who meet the inclusion/exclusion criteria listed and also are are excluded for treatment with the Parachute Implant System due to anatomical characteristics such as obstructing pseudochordae, calcification, or wall thickness. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parachute Implant System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Volume Index | An improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure. | 0 days (at implant) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at least 18 years of age with symptoms of heart failure and anteroapical wall motion abnormality due to myocardial infarction.
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| Name | Affiliation | Role |
|---|---|---|
| Helge Möllmann, MD | Kerckhoff Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Research GmbH | Dortmund | Hohe Straße 1 | Dortmund | Germany | ||
| Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie |
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| Essen |
| Klara-Kopp-Weg 1 |
| 45138 |
| Germany |
| Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie | Düsseldorf | Moorenstr. 5 | 40225 | Germany |
| Uniklinik Aachen | Aachen | 52074 | Germany |
| Kerckhoff-Klinik gGmbH | Bad Nauheim | 61231 | Germany |
| Unfalkrankenhaus Berlin | Berlin | Germany |
| University Köln | Cologne | 50937 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Asklepios Klinik St. George | Hamburg | 20099 | Germany |
| Universitäres Herzzentrum Hamburg Eppendorf GmbH | Hamburg | 20251 | Germany |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
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