Cardiogenic ShockNCT02279979
Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
A study testing HeartMate PHP in people with Cardiogenic Shock, run by Abbott Medical Devices at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- HeartMate PHP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Oct 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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
- Written, signed, and dated informed consent
Who cannot join
- Patient is >85 years of age
- Right ventricular failure requiring mechanical circulatory support
- ST elevation myocardial infarction (STEMI) within 30 days of procedure
- Cardiac arrest within 7 days of procedure requiring CPR
- Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc.
- Documented acute myocarditis
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- Active major cardiac rhythm disturbances (e.g., ventricular tachycardia, ventricular fibrillation).
- Hypertrophic disease or any left ventricular outflow tract obstruction
- Active sepsis defined as bacteremia, fever ≥ 101.5 degrees F
- Mural thrombus in the left ventricle
- History of aortic valve replacement
- End-stage renal disease requiring dialysis
- Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less)
- Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
- Platelet count < 100,000
- Allergy or Intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
- Known coagulopathies
- Presence of risk factors for severe liver and/or renal dysfunction
- Stroke within 90 days of enrollment
- Significant peripheral vascular disease
- History of heparin induced thrombocytopenia
- Patient is pregnant or planning to become pregnant during the study period
- Patient is breastfeeding.
- 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.
- Any active disease in which the investigator determines would make the patient an inappropriate candidate for the study.
- Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Czechia2 sites
Na Homolce Hospital
Prague, 130 50
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 140 21
Germany2 sites
Universitätskliniken Düsseldorf
Düsseldorf, 40225
Medizinische Hochschule Hannover
Hanover, 30625
About this study
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.
Read the 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
- Cardiogenic Shock
- Being tested
- HeartMate PHP
- Keywords
- PHP, Cardiogenic Shock, Percutaneous, Ventricular Assist, Heart Pump, Catheter, Thoratec Corporation
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartMate PHPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | All enrolled patients will be treated with the HeartMate PHP device Receives: Device: HeartMate PHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2
Measured: 72 hours
Secondary outcomes (1)
An assessment of major adverse events
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Pooja Chatterjee, Study director, Thoratec LLC, St. Jude Medical, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279979
- Sponsor's protocol ID
- Thoratec HeartMate PHP™ CS
- Status last verified
- Jul 2023
- First submitted
- 29 Oct 2014
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
- ClinicalTrials.gov ID
- NCT02279979
- Acronym / sponsor ID
- Thoratec HeartMate PHP™ CS
- Conditions
- Cardiogenic Shock
- Keywords
- PHP, Cardiogenic Shock, Percutaneous, Ventricular Assist, Heart Pump, Catheter, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- Oct 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: HeartMate PHPAll enrolled patients will be treated with the HeartMate PHP device |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- Patient is >85 years of age
- Right ventricular failure requiring mechanical circulatory support
- ST elevation myocardial infarction (STEMI) within 30 days of procedure
- Cardiac arrest within 7 days of procedure requiring CPR
- Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartMate PHPThe 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. | Device | Treatment Arm |
Primary outcome
Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2
Time frame: 72 hours
1 secondary outcome
An assessment of major adverse events
Time frame: 72 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooja Chatterjee study director
Thoratec LLC, St. Jude Medical, Abbott
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartMate PHP in people with Cardiogenic Shock, run by Abbott Medical Devices at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Czechia, Germany, Hungary, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2 (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.