Aortic Stenosis Clinical Trial
Official title:
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04310046 -
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
|
N/A | |
| Completed |
NCT03332745 -
Mechanism of Decompensation Evaluation - Aortic Stenosis
|
||
| Recruiting |
NCT06008080 -
Post-Market Clinical Follow Up Study With Navitor Valve
|
||
| Recruiting |
NCT06055751 -
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
|
||
| Active, not recruiting |
NCT04815785 -
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
|
N/A | |
| Terminated |
NCT02202434 -
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
|
N/A | |
| Recruiting |
NCT03029026 -
The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
|
||
| Active, not recruiting |
NCT02903420 -
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
|
N/A | |
| Completed |
NCT02629328 -
CardioCel Tri-leaflet Repair Study
|
N/A | |
| Completed |
NCT02306226 -
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
|
||
| Completed |
NCT01676727 -
ADVANCE Direct Aortic Study
|
||
| Withdrawn |
NCT01648309 -
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
|
N/A | |
| Completed |
NCT01422044 -
Risk Prediction in Aortic Stenosis
|
N/A | |
| Withdrawn |
NCT00774657 -
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography
|
N/A | |
| Terminated |
NCT00535899 -
Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)
|
N/A | |
| Terminated |
NCT05070130 -
OpSens PRIME CLASS
|
||
| Completed |
NCT03314857 -
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
|
N/A | |
| Completed |
NCT04157920 -
Impact of Predilatation Between Self-expanding Valves
|
N/A | |
| Enrolling by invitation |
NCT06212050 -
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
|
||
| Recruiting |
NCT05893082 -
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
|
N/A |