Clinical trial NCT03683355: Characterization of RadiOlabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves.
Official title: Characterization of Radiolabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves. The COUNT Study. A Prospective, Observational Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Infective Endocarditis
Keywords: Transcatheter aortic valve replacement
Infective endocarditis
Radionuclide imaging
Radiolabeled tracer uptake pattern
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing TAVR procedure with Edwards Sapien 3 and Core Valve Evolut R devices.

Brief summary: Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer (18F-FDG) uptake in noninfected transcatheter heart valves in early follow-up after transcatheter aortic valve replacement (TAVR).

Detailed description: Diagnostic accuracy of Infective endocarditis (IE) is commonly challenging. Current clinical guidelines recommend the use of the modified Duke criteria, based on clinical, echocardiographic and biological findings, as well as the results of blood cultures and serologies. Advances in imaging techniques have resulted in an improvement in the identification of endocardial involvements and extracardiac complications of IE. Thus, recent works have demonstrated that 18F-FDG PET/CT and radiolabeled leucocyte SPECT/CT may improve the detection of silent endocardial lesions. The sites of radiotracer accumulation show regions of a high metabolic activity due to an inflammation or infection process. It is well known that, in surgical prosthetic valves, a mild radiotracer uptake in the perivalvular area may occur in the absence of infection and could therefore be considered as a normal pattern, particularly early after valve replacement. However, evidence of this phenomenon is lacking regarding transcatheter heart valves and the factors used to distinguish between normal and abnormal patterns of radiolabeled tracer are not standardized. The hypothesis is that patients undergoing transcatheter aortic valve replacement (TAVR) show a radiolabeled tracer (18F-FDG) uptake around the prosthesis despite the absence of IE. Moreover, the uptake pattern might vary between different platforms.

Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer uptake in noninfected transcatheter heart valves in early follow-up after TAVR.

This will be a pilot study including 30 patients after TAVR procedure.

Eligibility criteria: Inclusion Criteria:

* Patients \>18-year-old undergoing TAVR procedure with Edwards Sapien 3 and Core Valve Evolut R devices.
* Informed written consent

Exclusion Criteria:

* Inability to provide signed informed consent.
* Patients with definitive or possible IE according to modified Duke criteria and current clinical guidelines for the management of IE.
* Any contraindication for 18F-FDG PET/CT.
* Any condition making it unlikely the patient will be able to complete the protocol procedures and follow-up visits.

Primary outcomes:
measure: Radiolabeled tracer uptake grade (intense, moderate, mild or absent) in the prosthetic and periprosthetic areas.
timeFrame: 3 months after TAVR
Secondary outcomes:
measure: Maximal standardized uptake value (SUVmax) using an average of 3 measurements from 3 volumes of interest (5mm3) introduced in the prosthetic region at equal distances from each other.
timeFrame: 3 months after TAVR
measure: Differences in radiolabeled tracer uptake grade in the prosthetic and periprosthetic areas between the Edwards valve versus the CoreValve valve.
timeFrame: 3 months after TAVR
measure: Correlation between radiolabeled tracer uptake grade and time from TAVR
timeFrame: 3 months after TAVR
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre de recherche de L'Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
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