To assess real world experience with HeartMate PHP post CE Mark approval in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing complex percutaneous coronary interventions (PCI).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Performance Evaluation:
Safety Endpoints: Outcomes and Adverse Events
* Death (including cardiac Death)
* 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 5)
Performance endpoints:
* Change in Mean Arterial Pressure from baseline (MAP
* 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
Percutaneous Coronary Intervention (PCI) has provided a significantly less
invasive alternative than traditional cardiothoracic surgery to treat patients
with severe coronary artery disease. A subset of patients undergoing PCI may
require the use of hemodynamic support devices such as intra-aortic balloon
pumps (IABP) or percutaneous left ventricular support devices in cases of
complex coronary anatomy or depressed left ventricular function as a result of
acute myocardial infarction and/or cardiogenic shock. These patients are at
risk of hemodynamic collapse during PCI due to decreases in coronary perfusion
during balloon inflations or in the event of complications such as vessel
occlusion or dissection. With advances in PCI technology and improvement in PCI
outcomes, an increasing number of patients with severe coronary disease and
comorbidities are undergoing PCI.
The need for devices that are able to provide better hemodynamic support than
that allowed by the IABP resulted in the development of percutaneous support
devices. Over 200 cases of percutaneous support devices have been reported in
literature to treat patient in cardiogenic shock, acute myocardiol infarction
and those undergoing high-risk PCI. Many of these publications have demostrated
the safe use and efficacy of this percutaneously placed devices.
In 2014 a CE mark clinical trial evaluating the use of the HeartMate PHP device
in patients with reduced left ventricular function who were at risk of
hemodynamic compromise while undergoing high-risk PCI was conducted. The device
received CE mark approval in EU. A total of 50 patients were enrolled in this
trial in 7 sites. Cardiac output and cardiac index were improved or mantained
throughout all cases during the PCI procedure, and all other hemodynamic
parameters were stable throughout all procedures.
The purpose of this post approval study is to evaluate the real world use of
HeartMate PHP device to support patients at risk of hemodynamic compromise
while undergoing complex PCI as a commitment to the CE Mark approval in the EU.
The data collection will be similar to the CE Mark study for ease of comparison
to the pre-market results and to continue to build a more robust HeartMate PHP
data set in patients undergoing complex PCI.
Study objective
To assess real world experience with HeartMate PHP post CE Mark approval in
supporting patients who are hemodynamically unstable, or at risk of being
hemodynamically unstable, while undergoing complex percutaneous coronary
interventions (PCI).
Study design
Prospective, nonrandomized, multi-center, open-label, post approval trial.
Data will be collected at baseline, during the PCI procedure, discharge, and at
30 days post device removal.
Intervention
use of PHP device during elective high risk PCI
Study burden and risks
The HeartMate PHP has received CE Mark approval for use in high-risk PCI in
Europe Extensive testing has been performed on the device in the laboratory and
in animal studies. The decision of the use of HeartmatePHP during the high risk
PCI is taken by the interventional cardiologist before the PCI procedure.
Participation in the study exposures the patient to potential extra risk due to
additional measurements by a right heart catheterization. This PCI procedure
will thereby potentially be extended by 30 minutes.
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.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
* At least 18 years of age.
* Patient presents with a non-emergent need for complex PCI and in the opinion of the investigator is a risk of hemodynamic compromise during PCI.
* 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 1.5cm2 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
*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
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 |
|---|---|
| CCMO | NL57557.078.16 |