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

NCT03683355 | Completed

• 1 other identifier: COUNT
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Infective Endocarditis

Keywords

Transcatheter aortic valve replacement; Infective endocarditis; Radionuclide imaging; Radiolabeled tracer uptake pattern

Outcome Measures

Primary Outcomes (1)

• Radiolabeled tracer uptake grade (intense, moderate, mild or absent) in the prosthetic and periprosthetic areas.

  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).

  3 months after TAVR

Secondary Outcomes (3)

• 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

• Differences in radiolabeled tracer uptake grade in the prosthetic and periprosthetic areas between the Edwards valve versus the CoreValve valve.

  3 months after TAVR

• Correlation between radiolabeled tracer uptake grade and time from TAVR

  3 months after TAVR

Study Arms (2)

Edwards Sapien 3

Patients who underwent transcatheter aortic valve replacement with the Edwards Sapien 3 valve

Radiation: 18F-FDG PET/CT

Core Valve Evolut R

Patients who underwent transcatheter aortic valve replacement with the Core Valve Evolut R valve

Radiation: 18F-FDG PET/CT

Interventions

18F-FDG PET/CT RADIATION

18F-FDG PET/CT and blood cultures will be performed at 3-month follow-up after TAVR Patients with positive 18F-FDG PET/CT (moderate or intense radiolabeled tracer uptake) will be scheduled for a second 18F-FDG PET/CT at 6-month follow-up.

Core Valve Evolut R; Edwards Sapien 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing TAVR procedure with Edwards Sapien 3 and Core Valve Evolut R devices.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead

Study Sites (1)

Centre de recherche de L'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (17)

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MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 25, 2018
• Study Start: November 9, 2018
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CA (1)