Brief Title
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
Official Title
18-F Sodium Fluoride (18F-NaF) Positron Emission Tomography (PET) for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
Brief Summary
This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters. Additionally, the data will serve as preliminary data to plan a larger study to investigate study objectives.
Detailed Description
This five-year pilot study will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters. Techniques that can identify specific increases in calcification activity are therefore likely to provide important insights into predicting the longevity of TAVR valves and guidance towards subsequent interventions. Twenty patients whom have undergone either TAVR or surgical bioprosthetic aortic valve replacement will be invited to participate in an 18F-NaF PET scan (baseline) and CT scan imaging (baseline and Year 2). Baseline, Year 1 and 2 will also include clinical assessment, labs and echocardiograms. Telephone contact at Years 3, 4, and 5 will provide follow up for major cardiovascular adverse events.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Presence of calcification activity within the replacement valve by 18F-NaF PET-CT
Condition
Aortic Stenosis
Intervention
18F-NaF
Study Arms / Comparison Groups
18F-NaF PET and CT scanning
Description: 18F-NaF PET-CT scan (at Baseline visit only) Contrast-enhanced CT Scan (at Baseline and Year 2 only) with possible beta-blocker and nitroglycerin, if medically safe.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
20
Start Date
July 23, 2017
Completion Date
December 31, 2026
Primary Completion Date
December 31, 2026
Eligibility Criteria
Inclusion Criteria: - Aged ≥60 years - Patients between 1 month and 5 years following transcatheter aortic valve replacement (TAVR) or surgical bioprosthetic aortic valve replacement Exclusion Criteria: - Inability to provide informed consent - Creatinine >1.5 mg/dL - History of severe allergy to iodine contrast agents - Active atrial fibrillation - Paget's disease - Metastatic malignancy
Gender
All
Ages
60 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Daniel S. Berman, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03095313
Organization ID
46429
Responsible Party
Principal Investigator
Study Sponsor
Cedars-Sinai Medical Center
Study Sponsor
Daniel S. Berman, MD, Principal Investigator, Cedars-Sinai Medical Center
Verification Date
March 2022