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.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary performance evaluation will be clinical stabilization at 72 hours.
Clinical stabilization is defined as:
- Improvement of CI to > 2.2 L/min/m2 as determined by average CI measurements
(acquired every 4 hours for up to 72 hours) compared to baseline. CI will be
measured using either the Fick or thermodilution methods.
Safety Evaluations will include:
- All Death
- Debilitating stroke (an acute episode of a focal or global neurological
deficit with at least one of the following: change in the level of
consciousness, hemiplegia, hemiparesis, numbness, or sensory loss affecting one
side of the body, dysphasia or aphasia, hemanopia, amaurosis fugax, or other
neurological signs or symptoms consistent with stroke lasting *24 h and
confirmed by neuroimaging [CT scan or brain MRI])
- Device related serious adverse event requiring device removal
- Bailout with an advanced mechanical circulatory support device other than
HeartMate PHP (e.g., ECMO)
- Addition of one or more inotrope(s) or vasopressor(s) above baseline OR a
doubling of inotrope/vasopressor dosage over baseline within 72 hours.
Hemodynamic Evaluations will include:
- 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)
Secondary outcome
not applicable
Background summary
The HeartMate PHP is a catheter-based axial flow pump designed to provide
partial left ventricular circulatory support.
Study objective
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.
Study design
Prospective, nonrandomized, controlled, single-arm, multi-center, open-label
trial.
Intervention
The HeartMate PHP is inserted percutaneously using standard techniques
for cardiac catheterization and angiography. As depicted in the illustration
below, the device itself consists of disposable components (catheter,
cannula and motor) and a PHP console, used to control the device.
The device is prepped and primed prior to insertion. Access to the femoral
artery is performed as per standard practice. Guidewire access to the left
ventricle is performed and the guidewire is then backloaded onto the device.
The device is then inserted percutaneous delivery via an integrated 12F
sheath through a 14F introducer and tracked over the guidewire to the left
ventricle. After verifying correct position across the aortic valve, the
guidewire is removed and the cannula expanded by pulling back the device
outer sheath. The pump is powered on via the console which controls pump
speed and displays estimated flow rate. The console also alerts the user to
any alarm conditions.
At the end of the procedure, the device is retracted to the descending aorta,
where it can be collapsed into the integrated sheath and removed from the
body.
Study burden and risks
The HeartMate PHP has been granted with CE-mark certificate that proofs
conformity with regulations for medical devices, yet has not been approved by
the U.S. Food and Drug Administration (FDA) or any other Regulatory Agency in
this indication. Extensive testing has been performed on the device in the
laboratory and in animal studies. The HeartMate PHP device has been
successfully used in a small group of patients.
Potential Complications
The risks associated with use of the HeartMate PHP are believed to be:
* Access Site Hematoma (bleeding from the leg area in which the HeartMate PHP
is inserted) (15-20%)
* Aortic Valve Insufficiency (leaking of a valve of the heart that causes blood
to flow in the reverse direction) (<5%)
* Aortic Valve Injury (<5%)
* Thromboembolism (blood clots that form and can travel to other parts of the
body which can result in a stroke or loss of a limb or injury to other organs
and which could require surgery) (<5%)
* Bleeding (10-15%)
* Cardiac Arrhythmias (irregular heartbeat) (<5%)
* Cardiogenic Shock (condition in which a suddenly weakened heart isn't able to
pump enough blood to meet the body's needs) (<5%)
* Cardiac Tamponade (condition in which blood or fluids fill the space between
the sac that encases the heart and the heart muscle, placing extreme pressure
on the heart) (<5%)
* Cerebrovascular Accident (brain dysfunction related to disease of the blood
vessels supplying the brain; also known as a stroke) (<5%)
* Death (<25%)
* Device Malfunction (the HeartMate PHP or one of its parts might break or fail
to work) (<5%)
* Hemolysis (breakdown of red blood cells) (<=5%)
* Hepatic Dysfunction (liver failure due to not enough blood flow to the liver)
(<5%)
* Hypertension (condition in which the blood pressure in the arteries is
elevated) (<5%)
* Insertion Site Infection (<5%)
* Left Ventricular Perforation (puncture injury to the left side of the heart)
(<5%)
* Myocardial Infarction (when blood stops flowing properly to part of the heart
and the heart muscle is injured due to not receiving enough oxygen) (5%)
* Renal Failure (condition in which the kidneys fail to adequately filter waste
products from the blood) (10%)
* Respiratory Dysfunction (<5%)
* Sepsis (severe blood infection) (10%)
* Thrombocytopenia (decreased number of platelets in the blood) (10%)
* Transient Ischemic Attack (when blood flow to a part of the brain stops) (<5%)
* Vascular Injury (blood vessel damage) (<10%)
* Venous Thromboembolism (blood clots that form in the veins and can detach
from the veins and travel to the lungs and get lodged in the arteries of the
lungs) (<5%)
Benefits of participating in this study:
The HeartMate PHP may provide additional pumping power to heart which it may
not be able to do on its own. This may potentially reduce or eliminate possible
problems associated with reduced heart pumping power and/or complex heart
disease.
Standaardruiter 13
Veenendaal 3905 PT
NL
Standaardruiter 13
Veenendaal 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. 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 (average over 4 hours) OR increased creatinine of 0.3 mg/dl from baseline obtained within 2 weeks, OR cool extremities
2. Written, signed, and dated informed consent
Exclusion criteria
1. Right ventricular failure requiring mechanical circulatory support
2. ST elevation myocardial infarction (STEMI) within 30 days of procedure
3. Cardiac arrest within 7 days of procedure requiring CPR
4. Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc.
5. Documented acute myocarditis
6. Hypertrophic disease or any left ventricular outflow tract obstruction
7. Active sepsis defined as bacteremia, fever * 101.5 degrees F
8. Mural thrombus in the left ventricle
9. History of aortic valve replacement
10. End-stage renal disease requiring dialysis
11. Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less)
12. Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
13. Platelet count < 100,000 x 109/L
14. Allergy or Intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
15. Known coagulopathies
16. Presence of risk factors for severe liver and/or renal dysfunction
17. Stroke within 90 days of enrollment
18. Significant peripheral vascular disease
19. History of heparin induced thrombocytopenia
20. Patient is pregnant or planning to become pregnant during the study period
21. Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02279979 |
| CCMO | NL55166.078.15 |