The primary objective is to evaluate the safety and efficacy of the PulseCath during support of patients with impaired ventricular function, for a period between 24 hours minimum and 14 days maximum. Safety will be assessed by the incidence of…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The procedure is considered safe when there were no CVA's, no thrombo-embolic
events, and the degree of hemolysis was manageable. The efficacy of the device
is considered established when the surgical introduction, positioning, fixation
and removal of the device has been performed without any injury of valvular or
vascular structures, and the device has not caused perfusion disorders of the
peripheral arteries. The hemodynamic performance of the device is considered
successful when CI > 2.5 L/min/m2 and MAP > 60 mmHg during all phases of the
procedure, and the renal and liver functions did not deteriorate.
Secondary outcome
Clinical success is achieved when the patient has successfully been weaned from
the device.
Background summary
The PulseCath is a catheter type ventricular assist device, CE certified for
supporting the left side of the heart for a period of 24 hours. This study is
set up to generate additional scientific information with the PulseCath in
patients who require left or right ventricular assist for a longer than 24 hour
period of time.
Study objective
The primary objective is to evaluate the safety and efficacy of the PulseCath
during support of patients with impaired ventricular function, for a period
between 24 hours minimum and 14 days maximum. 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, hemodynamic performance of the device and renal- and liver
function.
The secondary objective is to evaluate the cardiac function during use of the
PulseCath. The aim is to recover the patient or, in case recovery is not
possible, to win time in order to make a decision either to replace the
PulseCath by a (semi-) permanent ventricular assist device or to arrange a
heart transplant.
Study design
A prospective multi-centre single-arm feasibility study in 20 patients.
Intervention
The PulseCath will be inserted in the heart via the subclavian artery. The tip
(inflow) will be positioned in the heart while the outflow opening will be
positioned outside the heart, in the aorta.
Study burden and risks
The application of the PulseCath is equal to the standard procedures (IABP).
Both devices are inserted via a major artery, the IABP via the femoral artery,
the PulseCath via the subclavian artery.
Inherent to any invasive procedures, there are risks associated with the use of
the PulseCath. These potential complications include vascular damage to the
subclavian artery or the aorta, thrombosis at the insertion site, thrombi in
the catheter, injury of a heart valve and ischemia of the arm due to
obstruction of the subclavian artery.
The benefit of the use of the PulseCath is that the pump ensures improved blood
flow to the cardiac tissue and major organs, thereby improving the perfusion
and thus function. The aim is that this will lead, either to recovery of the
patient, or to an extended time period for the clinician to consider further
treatment. Further treatment could include for example the implantation of a
(semi-) permanent ventricular assist device or the arrangement of a heart
transplant.
Orlyplein 85
1043 DS Amsterdam
NL
Orlyplein 85
1043 DS Amsterdam
NL
Listed location countries
Age
Inclusion criteria
• Cardiac index (CI) < 2.2 L/min/m2, pre-PulseCath, despite appropriate inotropic support and/or IABP
• Mean arterial pressure (MAP) < 60 mmHg, pre-PulseCath, despite appropriate inotropic support and/or IABP
• Expected duration of support by the PulseCath: 24 hours to 14 days
• Patient older than 18 years
• Patient or legal representative has signed the Informed Consent
Exclusion criteria
• Aortic disease: ascending aortic aneurism, severe calcified aorta
• Aortic valvular disease: aortic valve stenosis, aortic valve insufficiency
• Aortic valve prosthesis
• Subclavian artery stenosis in case of insertion via subclavian artery
• Thrombus in left ventricle
• No residual function of the left ventricle
• No functioning right ventricle
• History of coagulation disorders
• Previous history of CVA within the last 12 months
• Liver dysfunction, evidenced by: ALT > 100 U/L (men) > 70 U/L (women) or AST > 100 U/L (men) > 70 U/L (women)
• Patients with chronic renal failure requiring dialysis
• 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 | NL28842.042.09 |