High Risk Percutaneous Coronary InterventionHM PHP CE MarkNCT02156609
HeartMate PHP™ CE Mark Clinical Investigation Plan
A study testing Percutaneous ventricular support with the HeartMate PHP in people with High Risk Percutaneous Coronary Intervention, run by Abbott Medical Devices at 7 sites in 4 countries.
Trial summary
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk Percutaneous Coronary Intervention
- What is being tested?
- Percutaneous ventricular support with the HeartMate PHP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jun 2014to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Patient presents with a non-emergent need for complex PCI with:
- an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND
- the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery
- Written, signed, and dated informed consent
Who cannot join
- Emergent PCI
- ST elevation myocardial infarction within 7 days of procedure
- Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
- Hemodynamic support with the HeartMate PHP post-PCI is anticipated
- Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index <2.2 L/min/m2)
- Mural thrombus in the left ventricle
Show all 21Show fewer
- History of aortic valve replacement
- Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
- Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
- Severe peripheral vascular disease
- Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
- Planned use of rotablator or atherectomy during the procedure
- Serum creatinine > 3.5mg/dL within 7 days of procedure
- Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥2
- Uncorrectable abnormal coagulation parameters
- Active systemic infection requiring treatment with antibiotics
- Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction
- Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
- History of heparin induced thrombocytopenia
- Patient is pregnant or planning to become pregnant during the study period
- Participation in another clinical study of an investigational drug or device that has not met its primary endpoint-
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Poland4 sites
Samodzielny Publiczny Szpital (The Prof. Leszka Gieca Upper-Silesian Medical Centre)
Katowice, 40-635
University Hospital in Krakow (John Paul II)
Krakow, 31-202
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, 04-628
Slaskie Centrum Chorob Serca w Zabrzu (Silesian Center for Heart Disease)
Zabrze, 41-800
About this study
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.
Read the detailed description
The HeartMate PHP (percutaneous heart pump) is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. The primary objective of this prospective, nonrandomized, multi-center, open-label trial is to assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI).
- Being tested
- Percutaneous ventricular support with the HeartMate PHP
- Keywords
- HeartMate PHP, HeartMate PHP CE Mark, Percutaneous coronary intervention, PCI, Percutaneous ventricular assist, Thoratec Corporation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous ventricular support with the HeartMate PHPDevice
The HeartMate PHP device will be inserted percutaneously prior to the start of high risk coronary interventions (complex disease, reduced ejection fraction, etc.) to provide hemodynamic support,
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous coronary intervention | Experimental | Percutaneous ventricular support with the HeartMate PHP during high risk percutaneous coronary intervention Receives: Device: Percutaneous ventricular support with the HeartMate PHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Primary Performance Endpoint:
Freedom from hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required.
Primary Endpoint will be evaluated at:
- Post procedure or at hospital discharge (whichever is longer)
- 30 days post procedure
Measured: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Composite of Major Adverse Events (MAE)
Primary Safety Endpoint:
Composite of Major Adverse Events (MAE):
- device-related cardiac death,
- new Q wave myocardial infarction,
- surgical intervention due to device complication or malfunction,
- device-related access site complication requiring intervention or device-related limb ischemia,
- cerebral vascular accident (CVA),
- new or worsening aortic valve insufficiency,
- major bleeding complication (BARC 3 or >),
- severe hypotension
Primary Endpoint will be evaluated at:
- Post procedure or at hospital discharge (whichever is longer)
- 30 days post procedure
Measured: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Secondary outcomes (2)
Secondary Endpoint
Efficacy of hemodynamic support as measured by:
- Maximal decrease in cardiac power output (CPO) from baseline
- Changes in central venous pressure from baseline (CVP)
- Changes in pulmonary artery pressure from baseline (PAP)
- Changes in pulmonary capillary wedge pressure from baseline (PCWP)
- Changes in cardiac output from baseline (CO)
- Changes in cardiac index from baseline (CI)
Measured: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Major Adverse Event Composites
Individual components of the major adverse event composites
Measured: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Percutaneous Coronary InterventionStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dariusz Dudek, MD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156609
- Sponsor's protocol ID
- PHPCEMark
- Acronym
- HM PHP CE Mark
- Status last verified
- Jun 2022
- First submitted
- 29 May 2014
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartMate PHP™ CE Mark Clinical Investigation Plan
- ClinicalTrials.gov ID
- NCT02156609
- Acronym / sponsor ID
- HM PHP CE Mark / PHPCEMark
- Keywords
- HeartMate PHP, HeartMate PHP CE Mark, Percutaneous coronary intervention, PCI, Percutaneous ventricular assist, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jun 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 HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.
Detailed description
The HeartMate PHP (percutaneous heart pump) is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. The primary objective of this prospective, nonrandomized, multi-center, open-label trial is to assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention | Experimental | Device: Percutaneous ventricular support with the HeartMate PHPPercutaneous ventricular support with the HeartMate PHP during high risk percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age.
- Patient presents with a non-emergent need for complex PCI with:
- Written, signed, and dated informed consent
Key exclusion criteria (21 listed)
- Emergent PCI
- ST elevation myocardial infarction within 7 days of procedure
- Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
- Hemodynamic support with the HeartMate PHP post-PCI is anticipated
- Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index <2.2 L/min/m2)
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 |
|---|---|---|
| Percutaneous ventricular support with the HeartMate PHPThe HeartMate PHP device will be inserted percutaneously prior to the start of high risk coronary interventions (complex disease, reduced ejection fraction, etc.) to provide hemodynamic support, | Device | Percutaneous coronary intervention |
Primary outcome
Primary Endpoint
Time frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Primary Performance Endpoint: Freedom from hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required. Primary Endpoint will be evaluated at: * Post procedure or at hospital discharge (whichever is longer) * 30 days post procedure
Composite of Major Adverse Events (MAE)
Time frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Primary Safety Endpoint: Composite of Major Adverse Events (MAE): * device-related cardiac death, * new Q wave myocardial infarction, * surgical intervention due to device complication or malfunction, * device-related access site complication requiring intervention or device-related limb ischemia, * cerebral vascular accident (CVA), * new or worsening aortic valve insufficiency, * major bleeding complication (BARC 3 or >), * severe hypotension Primary Endpoint will be evaluated at: * Post procedure or at hospital discharge (whichever is longer) * 30 days post procedure
2 secondary outcomes
Secondary Endpoint
Time frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Major Adverse Event Composites
Time frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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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.
Dariusz Dudek, MD principal investigator
Jagiellonian University
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous ventricular support with the HeartMate PHP in people with High Risk Percutaneous Coronary Intervention, run by Abbott Medical Devices at 7 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 5 inclusion and 21 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: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland, Colombia, Netherlands, Paraguay. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Endpoint (time frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure). The study lists 2 primary outcomes in all. 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 24 Jun 2022.