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| Name | Class |
|---|---|
| Thoratec Corporation | INDUSTRY |
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The primary objective of this study is to assess reasonable safety and performance of the HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.
The HeartMate PHP is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. This prospective, nonrandomized, controlled, single-arm, multi-center, open-label trial will evaluate the safety and performance of the device in patients with cardiogenic shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | All enrolled patients will be treated with the HeartMate PHP device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartMate PHP | Device | The HeartMate PHP system is a catheter-based heart pump and console designed to provide hemodynamic left ventricular support for up to 3 days to stabilize patients by maintaining adequate systemic cardiac output. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2 | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| An assessment of major adverse events | 72 hours |
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Inclusion Criteria:
Patient is indicated for left ventricular support according to current medical guidelines ("current medical guidelines" applies only to patients enrolled in Germany)
Patient has a cardiac index of < 2.2 L/min/m2 and is being treated with at least one moderate dose inotrope or at least one moderate dose of vasopressor (e.g., milrinone ≥0.3 mcg/kg/min, dopamine > 5 mcg/kg/min, dobutamine > 5 mcg/kg/min) AND:
Written, signed, and dated informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Chatterjee | Thoratec LLC, St. Jude Medical, Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Prague | 130 50 | Czechia | |||
| Institute for Clinical and Experimental Medicine (IKEM) |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Prague |
| 140 21 |
| Czechia |
| Universitätskliniken Düsseldorf | Düsseldorf | 40225 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Semmelweis University Heart and Vascular Center | Budapest | 1122 | Hungary |
| Erasmus Medical Center | Rotterdam | 3000-CA | Netherlands |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |