18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:60 - Any
Updated:7/27/2018
Start Date:May 23, 2017
End Date:December 31, 2023
Contact:Daniel S. Berman, MD
Email:bermand@cshs.org
Phone:310 423-4223

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18-F Sodium Fluoride (18F-NaF) Positron Emission Tomography (PET) for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes

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.

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.

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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Daniel S Berman, MD
Phone: 310-423-4223
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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