Characterization of RadiOlabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves.

Active, not recruiting

• Conditions: Infective Endocarditis
• Interventions: Radiation: 18F-FDG PET/CT

• Registration Number: NCT03683355
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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.

Study Timeline

• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Study Start: 2018-11-09
• Primary Completion: 2022-03-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Edwards Sapien 3	18F-FDG PET/CT	Patients who underwent transcatheter aortic valve replacement with the Edwards Sapien 3 valve
Core Valve Evolut R	18F-FDG PET/CT	Patients who underwent transcatheter aortic valve replacement with the Core Valve Evolut R valve

Primary Outcome Measures

Name	Time	Method
Radiolabeled tracer uptake grade (intense, moderate, mild or absent) in the prosthetic and periprosthetic areas.	3 months after TAVR	Visual analysis grading the radiolabeled tracer molecules uptake in the prosthetic and periprosthetic areas as intense, moderate, mild or absent. This visual analysis will be defined whether the PET/CT was positive (intense/moderate) or negative (mild/absent).

Secondary Outcome Measures

Name	Time	Method
Differences in radiolabeled tracer uptake grade in the prosthetic and periprosthetic areas between the Edwards valve versus the CoreValve valve.	3 months after TAVR	Differences in radiolabeled tracer uptake pattern with different valves: Edwards THV vs CoreValve THV
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.	3 months after TAVR	The intensity of the radiolabeled tracer uptake will be determined by measuring the maximal standardized uptake value (SUVmax)), which is obtained by normalizing the tissue concentration of the radiolabeled tracer activity and the patient's weight. SUVmax will be calculated using an average of 3 measurements from 3 volumes of interest (5mm3) introduced in the prosthetic region at equal distances from each other. The prosthetic valve-to-background ratio will be calculated by dividing the prosthetic valve SUV max by the atrial blood SUVmax.
Correlation between radiolabeled tracer uptake grade and time from TAVR	3 months after TAVR	Relationship between radiolabeled tracer uptake and time from the procedure

Trial Locations

Locations (1)

Centre de recherche de L'Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Quebec, Canada