Primary: Determine the incidence of HALT after PPVI on CT. Secondary: Relate the occurrence of HALT to blood biomarkers and flow profiles on MRI. Determine the ability to detect HALT by TTE in patients that underwent PPVI
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of HALT as detected by computed tomography CT on percutaneously
implanted pulmonary prosthetic heart valves.
Secondary outcome
Secondary, the relation of blood biomarkers and MRI flow profiles to HALT.
Incidence of HALT on TTE.
Background summary
Percutaneous pulmonary valve implantation (PPVI) is an effective procedure in
patients with congenital heart diseases involving the right ventricular outflow
tract (RVOT). Concerns have been raised about the incidence of PPVI
endocarditis that may be related to thrombus formation on the valve. Recently,
reports have emerged describing the occurrence of hypo-attenuating leaflet
thickening (HALT) on other transcatheter valves. It*s unknown if HALT also
occurs after PPVI and whether it is related to endocarditis. Furthermore,
little is known about the CT and MRI findings after PPVI.
Study objective
Primary: Determine the incidence of HALT after PPVI on CT.
Secondary: Relate the occurrence of HALT to blood biomarkers and flow profiles
on MRI. Determine the ability to detect HALT by TTE in patients that underwent
PPVI
Study design
Exploratory cross-sectional observational study.
Study burden and risks
As part of the study patients undergo a cardiac CT scan. Patients also undergo
a transthoracic echocardiogram (TTE), blood samples and an MRI scan which are
all part of the routine clinical care. Tests are planned to be performed on the
same day during a regular visit to the outpatient clinic.
For the cardiac CT scan the patient is exposed to ionizing radiation which
carries a small risk of future induced neoplasms. Furthermore, iodinated
contrast material is injected which carries a small risk of an allergic
reaction.
Blood samples are taken for which a venous puncture is needed. This carries a
negligible risk. The MRI scan is considered safe. Gadolinium based contrast
agent is administrated which carries a small risk of an allergic reaction.
The benefit for the patient may lie in the fact that a comprehensive analysis
of their prosthetic heart valve and heart is performed. Patients that underwent
PPVI remain under lifelong follow-up by a cardiologist; almost all have a
congenital heart defect and are likely to need to undergo additional invasive
or surgical procedures in the future. The information gained from this study
may aid planning future interventions.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Underwent PPVI
- Age > 18 years
Exclusion criteria
- Pregnancy
- Unwillingness to sign informed consent
- Known allergy to iodinated contrast material
- Indication to perform prehydration prior to intravenous contrast material
admin-istration according to the guidelines in the EMC
- Unwillingness to be informed about unrequested findings on the CT
Design
Recruitment
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 | NL71294.078.19 |