About this trial
This is a prospective study designed to evaluate the structural and functional integrity of transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further aims to confirm resolution of the early bioprosthetic valve thrombotic changes with anticoagulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of transcatheter or surgical bioprosthetic aortic valve implanted at least 48 hours prior to enrollment
Age 18 years or older
Ability to provide informed consent and follow-up with protocol procedures.
Disqualifiers
Renal insufficiency (creatinine > 1.5 mg/dL)
Known allergy to iodinated contrast agents
Trial design
Single group
Treatments tested in this trial
Warfarin
DrugPatients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy with Vitamin K antagonists (Warfarin) for 3 months with goal INR 2-3, followed by repeat contrast CT of the chest and transthoracic imaging. Repeat imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy.
Treatment groups
Trial outcomes
Primary outcomes
Frequency of patients with structural/functional abnormalities of bioprosthetic valves
Other outcomes
Percentage of patients with resolution of bioprosthetic valve thrombotic lesions with anticoagulation
Sponsors and contacts
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