Primary objective: To evaluate local implementation, safety, feasibility and efficacy of temporary RV support with the Impella RP circulatory support deviceSecondary objective: -To evaluate the effect of temporary RV support on several clinical and…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary safety endpoint: the occurrence of bleeding (BARC type 2 and above)
including tamponade & access site, hemolysis, thrombus formation in RA/RV/PA,
right heart valve dysfunction, and arrhythmias up to 30 days after implantation
Primary efficacy endpoint: improvements in cardiac index, inotrope dosage, LVAD
flow, pump parameters, urine production, lactate and SvO2 compared to baseline
and 4 and 24 hours after implantation
Secondary outcome
Secondary safety endpoint: MACE @ 30 days
Secondary efficacy endpoints:
• Successful weaning
• Duration of implantation procedure
• TAPSE, S RV and RV diameters compared to baseline at 24 and 48 hours after
implantation, after device removal and at 30 days/before hospital discharge
• ICU and hospital length of stay
• Survival at 30 days and 6 months
Background summary
Right ventricular failure refractory to medical therapy is a complication that
can arise post-LVAD implantation, after a conventional cardiac surgical
procedure or as a consequence of an acute myocardial infarction (MI). It is
associated with significant morbidity and mortality. Short-term mechanical
support of the RV may be beneficial for these patients as a bridge to recovery,
as has been demonstrated in several previous studies involving invasive devices
such as TandemHeart or surgically implantable RVADs. Recently, however, a more
readily available and minimally invasive percutaneous support device for the RV
has been developed for this purpose.
Study objective
Primary objective:
To evaluate local implementation, safety, feasibility and efficacy of temporary
RV support with the Impella RP circulatory support device
Secondary objective:
-To evaluate the effect of temporary RV support on several clinical and
hemodynamic parameters
-To develop a *safety-net* for potential LVAD-candidates at risk for transient
postoperative RV dysfunction
-To further expand and develop expertise in the field of short-term mechanical
circulatory support also with regard to right heart failure
Study design
a prospective, non-randomized, non-blinded safety-and-feasibility study
Intervention
after evaluation of in-and exclusion criteria and after obtaining informed
consent, the Impella RP percutaneous right ventricular assist device is
implanted in patients with RV failure refractory to medical treatment, who are
being monitored in the intensive cardiac care unit (ICCU) or intensive care
unit 1 (ICV1).
Study burden and risks
Implantation of and treatment with the Impella RP4.0 percutaneous right
ventricular assist device is associated with certain risks. However, patients
included in this study, suffering of medical treatment-refractory RV failure,
have a dismal prognosis. As these patients could benefit from support with the
Impella RP4.0 device, the risk-benefit ratio is acceptable.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Age >18 years of age
- Setting: post-LVAD, post-cardiotomy, post-myocardial infarction
- Refractory RV failure, defined as a cardiac index of <2.2 l/min/m2 despite inhaled nitric oxide, continuous infusion of high-dose inotropes (dobutamine >10ug/kg/min or equivalent for >120 minutes) or the administration of >1 vasopressor/inotrope AND at least 1 of the following:
-central venous pressure (CVP) >18 mmHg
-CVP/pulmonary capillary wedge pressure or left atrial pressure ratio of >0.63
-global echocardiographic RV dysfunction, defined as a tricuspid annular systolic excursion (TAPSE) of <16mm, RV base diameter of >42 mm or RV short-axis/midcavity diameter of >35 mm
Exclusion criteria
Definite exclusion criteria
-profound cardiogenic shock, defined as a cardiac index of <1.3 and signs of irreversible multi-organ failure despite infusion of inotropes and/or vasopressors and LVAD therapy
-SOFA score >10
-the presence of a thrombus in the right atrium, right ventricle or pulmonary artery
-mechanical prosthetic tricuspid or pulmonary valve
-severe tricuspid or pulmonary valve stenosis
-pulmonary embolism
-anatomic conditions precluding pump insertion
-documented deep venous thrombosis or presence of an inferior vena cava filter;Relative exclusion criteria
-severe pulmonary hypertension, defined as a systolic pulmonary artery pressure of >60mmHg
-RV failure post-cardiac transplant
-severe tricuspid or pulmonary valve regurgitation
-severe active infection, defined as 2 or more of the following: a temperature of >38.5 C or <35.5 C, WBC of >12 000 or <4 000, heart rate of >90 bpm and respiratory rate of >22/min
-known coagulopathy
-implantation of permanent pacemaker within three months before study inclusion
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 |
|---|---|
| Other | 27592 |
| CCMO | NL62837.078.17 |