This is a mechanistic exploratory study. The objective of this study is to determine the effects of PulseCath® iVAC2L on ventricular loading conditions and assess impact on specific load and flow dependent humoral factors as well as cardiac enzymes…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pressure volume area (PVA) measurements will be taken at baseline, at
successive regular time points during the LVAD use, at the end of the
intervention, and after device removal. Impact on Myocardial Oxygen Consumption
(MVO2) will be inferred from the PVA
Secondary outcome
Hemodynamic assessment: Cardiac Output (CO), Cardiac Index (CI), End-Expiratory
Mean Pulmonary Capillary Wedge Pressure (PCWP), PCWP v-wave (vPCWP), Mean
Pulmonary Artery Pressure (mPAP), Left ventricle (LV) volumes and pressure
during the cardiac cycle, PV area (PVA), Preload Recruitable Stroke Work
(PRSW), Systolic and Diastolic Wall Stress (WSes and WSed), Starling
Contractile Index (SCI). Total Systemic Resistance (TSR), Total Pulmonary
Resistance (TPR), Cardiac Power Output (CPO). Blood samples: Hematocrit,
Hemoglobine, Platelet Count, Haptoglobin, hs-Troponin, CK, CK-MB mass assay,
NTpro-BNP, Serum Lactate, LDH, Total and Conjugated Bilirubin, Serum
Creatinine. Transthoracic Echocardiography: LVEDD, LVESD, LVEDV, LVESV, IVSTd,
PWTd, EF, degree of mitral regurgitation, Trans-Aortic Gradient, aortic
regurgitation, trans-mitral diastolic inflow pattern, tissue Doppler E/e*,
Tricuspid Regurgitation indicators including TR signal, and IVC assessment.
Background summary
Percutaneous mechanical circulatory support (MCS) is increasingly recognized as
an important adjunct in the management of challenging coronary anatomies in
high risk patients among other conditions. Heart teams may select patients for
percutaneous coronary intervention over coronary artery bypass grafting (CABG)
despite the presence of high-risk features like poor left ventricular function,
high SYNTAX score and hemodynamic instability. Percutaneous mechanical support
may also complement treatment of cardiogenic shock performing as a rescue or
limiting the need for inotropes and vasopressors which are known to increase
myocardial oxygen consumption and worsen prognosis. As defined by the 2015
Society for Cardiovascular Angiography and Interventions/American College of
Cardiology/Heart Failure Society of America/Society of Thoracic Surgeons
Clinical Expert Consensus on the use of percutaneous MCS in cardiovascular
care, the purpose of MCS is to reduce left ventricular stroke work and
myocardial oxygen demand while maintaining systemic and coronary perfusion in
the setting of cardiogenic shock; or to provide hemodynamic support during
complex cardiac procedures including HR-PCI (class IIb) and certain high-risk
ablation procedures.
Pulsatile and continuous flow support devices are available. A
pulsatile device like the Intra-Aortic Balloon Pump (IABP) offers diastolic
augmentation to increase myocardial perfusion and reduces afterload during
systole to promote forward flow from the Left Ventricle. The hemodynamic
support is modest and approximates 0.3 to 0.5 L/min.
The Impella (Abiomed Inc., Danvers, Massachusetts) is the first
commercial percutaneously inserted continuous flow system to unload the
ventricle by pumping aspirated blood from the Left Ventricle into the ascending
aorta. The FDA approved the Impella 2.5 for use in HR-PCI. Both Impella 2.5 and
Impella CP can provide antegrade flow of up to 2.5 L/min and 4.0 L/min
respectively. So far, randomized trials within the HR-PCI context could not
detect significant differences in clinical endpoints with pulsatile vs.
continuous flow support. The PulseCath® iVAC2L (PulseCath BV, Amsterdam, the
Netherlands) is a new pulsatile design that is inserted across the aortic valve
into the Left Ventricle and driven by a genuine IABP console. It may generate a
pulsatile flow of 1.5L/min on top of the existing cardiac output. PulseCath®
iVAC2L obtained CE mark approval for commercial use in Europe in February 2014.
The difference in hemodynamic performance and impact on ventricular
loading between pulsatile and continuous flow circulatory support systems is
unknown. Knowledge of optimal patterns may help in determining the ideal
circulatory device platform. If a difference is demonstrated, a randomized
trial could be designed to detect differences in clinical outcome between
pulsatile vs. standard-of-care continuous flow circulatory
support.
Study objective
This is a mechanistic exploratory study. The objective of this study is to
determine the effects of PulseCath® iVAC2L on ventricular loading conditions
and assess impact on specific load and flow dependent humoral factors as well
as cardiac enzymes during and after ventricular support in HR-PCI. In this
pilot study, thirty cases will be treated with the PulseCath® iVAC2L. 03
additional patients will be treated with the Impella CP following the same
experimental protocol.
Study design
This is an Investigator initiated, international, multicenter, prospective,
observational study, enrolling 30 consecutive patients who undergo HR-PCI with
PulseCath® iVAC2L support. Need for circulatory support will be confirmed by
heart team consensus. All patients are hemodynamically monitored throughout the
procedure in the catheterization laboratory with a Swan-Ganz pulmonary artery
catheter. A left ventricular PVL catheter will be inserted to determine LV
loading conditions. An additional of 03 patients will be treated with the
Impella CP in order to adequately compare the most powerful percutaneous
continuous flow system with PulseCath® iVAC2L. The PulseCath patients will be
enrolled in Rotterdam (The Netherlands), London (UK) and Toulouse (France). The
PulseCath® iVAC2L is CE marked in Europe but not yet FDA approved in the USA.
The period of follow up will be 30 days and the estimated time for enrollment
will be 1 year.
Intervention
High risk percutaneous coronary interventions will be conducted in patients
selected for the study in conformity with the previously mentioned criteria.
Interventions conducted in Rotterdam (NL), Toulouse(FR), and London (UK) will
be undertaken in conformity with local standards of practice. Patients with
increased risk of procedural complications due to advanced ischemic
cardiomyopathy and / or atherosclerotic disease will receive percutaneous
therapy for stable coronary heart disease under two different types of MCS.
Conductance catheters will be used to obtain high fidelity measurements of the
resulting gain in ventricular mechanics and energetics.
Study burden and risks
The proposed study aims to elucidate the differences in hemodynamical
performance between the continuous flow left ventricular assistance device
(CFLVAD) Impella CP and the new technology PulseCath® iVAC2L, together with
clinical outcomes at 30 days. The PulseCath® iVAC2L pulsatile flow left
ventricular assistance device (PFLVAD) can bring benefit mainly by keeping
minimal hemodynamic conditions to assure the perfusion of the myocardium and
major organs during peri-procedural episodes of circulatory instability.
Overall, previous reports in the literature on the benefits of percutaneous
LVADs indicate that its use reduces endothelin release, calcium overload, and
the rate of apoptosis through better LV unloading. In addition, it shifts the
balance between myocardial oxygen supply and demand to a more favorable
pattern, contributing to reduce the infarct size. And finally, it can
potentially improve procedural efficacy by allowing a more meticulous approach
to coronary lesions, improving the subsequent outcomes. Potential risks related
to the use of PulseCath® iVAC2L are similar to those derived from the use of
other LV-to-Aorta percutaneous devices such as the Impella CP, consisting on
access site complications, thromboembolic phenomena, mild and severe bleeding,
hemolysis, damage to the aortic and mitral valves, acute kidney injury,
myocardial infarction, stroke, arrhythmia, death, infection, LV perforation,
aortic dissection, limb ischemia.
Dr. Molewaterplein 40 Office Nt 645
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40 Office Nt 645
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Signed Informed Consent form
Patient older than 18 years
Clinical criteria: The multidisciplinary heart team has reached consensus for high-risk PCI. Anatomical criteria: Intervention to an unprotected left main coronary artery, left main equivalent or single remaining vessel; multivessel disease; intervention in a distal left main bifurcation. Specific to the French site: Affiliation to Health Insurance
Exclusion criteria
1) No written informed consent
2) Left ventricular thrombus
3) Intervetricular septal defect
4) Significant peripheral arterial disease or arterial lumen size < 6mm at the level of the common femoral artery.
5) Significant aortic valve disease (more than mild aortic stenosis/regurgitation)
6) Cardiogenic shock
7) Previous stroke within the last 3 months
8) Major bleeding event within last 3 months
9) Chronic kidney disease with a GFR < 25 mL/min
Criteria 10 to 12 are specific to the French site:
10) Women during pregnancy or lactation period according to the article L1121-5 of the CSP.
11) Vulnerable persons according to the article L.1121-6 of the CSP.
12) Persons subject to a legal protection measure or unable to express their consent according to Article L1121-8 of the CSP.
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 | NL58149.078.16 |