The primary objective is to evaluate the safety and efficacy of the PulseCath iVAC2L in highriskPCI patients who require left ventricular assistance. Safety will be assessed by theincidence of Cerebrovascular Accidents (CVA*s), thrombo-embolic…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Vascular therapeutic procedures
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The application of the device is considered safe when:
1) MACE < 20%
2) the degree of hemolysis was manageable
The efficacy of the device is considered established when:
1) the surgical introduction, positioning, fixation and removal of the iVAC2L
has been
performed without any injury of valvular or vascular structures, and the device
has not
caused perfusion disorders of the peripheral arteries
2) the hemodynamic parameters could be maintained according to the following
limits:
Cardiac Index > 2.5 L/min/m2; Mean Arterial Pressure > 60 mmHg, during the whole
duration of support by the iVAC2L
Clinical success is achieved when the patient has successfully been weaned from
the
device.
Secondary outcome
N.A.
Background summary
The PulsCath iVAC2L-heart pump is a newer version of an existing heart pump,
which is already on the market. Before the newer version can be registered,
investigation with patients should be done. This study is designed to
demonstrate that the pump is safe in use, and can assist to maintain sufficient
circulation.
Study objective
The primary objective is to evaluate the safety and efficacy of the PulseCath
iVAC2L in highrisk
PCI patients who require left ventricular assistance. Safety will be assessed
by the
incidence of Cerebrovascular Accidents (CVA*s), thrombo-embolic events and the
amount of
blood cell damage (hemolysis). Efficacy will be assessed in terms of technical
success and
hemodynamic performance of the device.
Study design
The study is a prospective single-centre, single-arm feasibility study.
The study will be performed in the hospital of the principal investigator.
Twent (20) patients will be included in the study and followed up to 1 day
after weaning of the iVAC2L, or, when earlier, to discharge.
The study will run for a period of maximal 12 months.
Intervention
prior to or during the treatment, the pulscath iVAC2L heart pump will be
inserted according to standard hospital prescription
Study burden and risks
Risks are valued as "high"
During use of the iVAC2L pump, the following measurements will be done:
invasive hemodynamics
blood tests to monitor anticoagulant, liver and kidney functions.
Orlyplein 85
Amsterdam 1043 DS
NL
Orlyplein 85
Amsterdam 1043 DS
NL
Listed location countries
Age
Inclusion criteria
* Indicated for High-Risk PCI, according to hospital standard procedure
* Indicated to have an IABP during the PCI, according to hospital standard procedure
* Expected duration of iVAC2L support: maximum 24 hours
* Patient older than 18 years
* Patient has signed the Informed Consent
Exclusion criteria
* Aortic disease: ascending aortic aneurism, severe calcified aorta
* Aortic valvular disease: severe aortic valve stenosis, severe aortic valve insufficiency
* Aortic mechanical valve prosthesis
* Thrombus in left ventricle
* Intra ventricular septum defect
* Severe peripheral vascular disease
* No functioning right ventricle
* History of coagulation disorders
* Participation in another clinical study that may interfere with this study
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 | NL41304.078.13 |