## Protocol Section
### Identification Module
**NCT ID:** NCT02279979

**Brief Title:** Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

**Official Title:** Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

#### Organization Study ID Info
**ID:** Thoratec HeartMate PHP™ CS
#### Organization
**Class:** INDUSTRY
**Full Name:** Abbott Medical Devices
### Status Module
#### Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-21

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-20

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Start Date
**Date:** 2014-10

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2014-10-31
**Type:** ESTIMATED
**Study First Submit Date:** 2014-10-29
**Study First Submit QC Date:** 2014-10-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Thoratec Corporation

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Abbott Medical Devices

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Cardiogenic Shock

**Keywords:**

- PHP

- Cardiogenic Shock

- Percutaneous

- Ventricular Assist

- Heart Pump

- Catheter

- Thoratec Corporation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All enrolled patients will be treated with the HeartMate PHP device

**Intervention Names:**

- Device: HeartMate PHP

**Label:** Treatment Arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment Arm

**Description:** 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.

**Name:** HeartMate PHP

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2

**Time Frame:** 72 hours

#### Secondary Outcomes

**Measure:** An assessment of major adverse events

**Time Frame:** 72 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patient is indicated for left ventricular support according to current medical guidelines ("current medical guidelines" applies only to patients enrolled in Germany)
2. 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:

   * PCWP \> 18 mmHg, AND
   * Systolic blood pressure \< 100 mmHg, AND
   * Decreased organ perfusion as evidenced by urine output of 50 mL/hr OR increased creatinine of 0.3 mg/dl from baseline obtained within 2 weeks, OR cool extremities
3. Written, signed, and dated informed consent

Exclusion Criteria:

1. Patient is \>85 years of age
2. Right ventricular failure requiring mechanical circulatory support
3. ST elevation myocardial infarction (STEMI) within 30 days of procedure
4. Cardiac arrest within 7 days of procedure requiring CPR
5. Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc.
6. Documented acute myocarditis
7. Active major cardiac rhythm disturbances (e.g., ventricular tachycardia, ventricular fibrillation).
8. Hypertrophic disease or any left ventricular outflow tract obstruction
9. Active sepsis defined as bacteremia, fever ≥ 101.5 degrees F
10. Mural thrombus in the left ventricle
11. History of aortic valve replacement
12. End-stage renal disease requiring dialysis
13. Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less)
14. Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
15. Platelet count \< 100,000
16. Allergy or Intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
17. Known coagulopathies
18. Presence of risk factors for severe liver and/or renal dysfunction
19. Stroke within 90 days of enrollment
20. Significant peripheral vascular disease
21. History of heparin induced thrombocytopenia
22. Patient is pregnant or planning to become pregnant during the study period
23. Patient is breastfeeding.
24. Any active disease (e.g., active cancer) which could affect the patient's participation in the study, or if life expectancy is less than 1 year.
25. Any active disease in which the investigator determines would make the patient an inappropriate candidate for the study.
26. Participation in another clinical study of an investigational drug or device that has not met its primary endpoint

**Maximum Age:** 85 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Prague

**Country:** Czechia

**Facility:** Na Homolce Hospital

**Zip:** 130 50

**Location 2:**

**City:** Prague

**Country:** Czechia

**Facility:** Institute for Clinical and Experimental Medicine (IKEM)

**Zip:** 140 21

**Location 3:**

**City:** Düsseldorf

**Country:** Germany

**Facility:** Universitätskliniken Düsseldorf

**Zip:** 40225

**Location 4:**

**City:** Hannover

**Country:** Germany

**Facility:** Medizinische Hochschule Hannover

**Zip:** 30625

**Location 5:**

**City:** Budapest

**Country:** Hungary

**Facility:** Semmelweis University Heart and Vascular Center

**Zip:** 1122

**Location 6:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Erasmus Medical Center

**Zip:** 3000-CA

#### Overall Officials

**Official 1:**

**Affiliation:** Thoratec LLC, St. Jude Medical, Abbott

**Name:** Pooja Chatterjee

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009203

- Term: Myocardial Infarction

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000007238

- Term: Infarction

- ID: D000007511

- Term: Ischemia

- ID: D000009336

- Term: Necrosis

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M15577

- Name: Shock

- Relevance: HIGH

- As Found: Shock

- ID: M15578

- Name: Shock, Cardiogenic

- Relevance: HIGH

- As Found: Cardiogenic Shock

- ID: M12155

- Name: Myocardial Infarction

- Relevance: LOW

- As Found: Unknown

- ID: M10282

- Name: Infarction

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012770

- Term: Shock, Cardiogenic

- ID: D000012769

- Term: Shock

### Misc Info Module

#### Removed Countries

- Country: Austria

- Country: Czech Republic

- Country: Slovenia

- Version Holder: 2024-05-24
