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).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 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
Secondary outcome
1) 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)
2) Individual components of the Major Adverse Event Composites
Secondary Endpoints will be evaluated at:
* Post procedure or at hospital discharge (whichever is longer)
* 30 days post procedure
Background summary
The HeartMate PHP system is a new catheter-based heart pump and console
designed to provide hemodynamic left ventricular support
during intraprocedural use to maintain adequate systemic cardiac output. The
key feature of the HeartMate PHP is its ability to be
deployed percutaneously via an integrated 12F arterial sheath through a 13F to
14F introducer. The catheter then expands to 24F when it is
deployed into the left ventricle across the aortic valve. This feature is made
possible by a collapsible impeller and cannula mechanism,
which is expanded upon deployment by the operator. The HeartMate PHP is
designed to provide flow up to 4.25L/min against a pressure of
62mmHg.
This study is designed to demonstrate that the pump is safe in use, and can
assist to maintain sufficient circulation. In addition thi study is part of the
procedure to receive a CE-mark for this device.
Study objective
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
Prospective, nonrandomized, multi-center, open-label trial
Intervention
The HeartMate PHP system is a catheter-based heart pump and console designed to
provide hemodynamic left ventricular support during intraprocedural use to
maintain adequate systemic cardiac output. The key feature of the HeartMate PHP
is its ability to be deployed percutaneously via an integrated 12F arterial
sheath through a 14F introducer. The catheter then expands to 24F when it is
deployed into the left ventricle across the aortic valve. This feature is made
possible by a collapsible impeller and cannula mechanism, which is expanded
upon deployment by the operator. The HeartMate PHP is designed to provide flow
of over 4 L/min against a pressure of 60 mmHg.
Data will be collected at baseline, during the PCI procedure, postprocedure,
discharge, and at 30 days post device removal. All patients will have a
follow-up visit at 30 days post-device removal.
Study burden and risks
The HeartMate PHP has not been approved for commercial distribution by the U.S.
Food and Drug Administration (FDA) or any other regulatory agency. Extensive
testing has been performed on the device in the laboratory and in animal
studies The potential risks associated with HeartMate PHP use are consistent
with those in procedures such as diagnostic cardiac angiography and
percutaneous coronary interventions. In addition to the potential risks
associated with those procedures, use of the HeartMate PHP may result in
additional potential risks such as those listed in
Section 16.1 (see protocol) Anticipated Potential Adverse Events.
The HeartMate PHP may provide hemodynamic support during high-risk PCI by
increasing output from the left ventricle to the ascending aorta at a rate up
to approximately 4 LPM. The potential benefits of hemodynamic support using the
HeartMate PHP include reduced or eliminated periods of coronary ischemia, more
complete revascularization than would be possible without HeartMate PHP
support, and reduction or elimination of intraprocedural complications such as
hypotension.
Fourth Avenue 23
Burlington MA 01803
US
Fourth Avenue 23
Burlington MA 01803
US
Listed location countries
Age
Inclusion criteria
- At least 18 years of age.
- Patient presents with a non-emergent need for complex PCI with:
1) an ejection fraction of <=35% requiring hemodynamic support during the procedure,
AND
2) 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
Exclusion criteria
- 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
- History of aortic valve replacement
- 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 )
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL48976.078.14 |