Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients with a history of bioprosthetic valve replacement undergo cardiac contrast CT imaging and transthoracic echocardiography to evaluate structural and functional integrity of the aortic valves. The imaging studies will be performed at least 48-hours after bioprosthetic valve replacement. Patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy, 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. I

Official Title
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Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Dysfunction With Multimodality Imaging and Its TrEatment With Anticoagulation

Conditions
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Prosthetic Valve Thrombosis

Intervention / Treatment
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* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Renal insufficiency (creatinine > 1.5 mg/dL) Known allergy to iodinated contrast agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-existing bioprosthetic aortic valve<br>Patients with a history of surgical or transcatheter valve replacement with bioprosthetic valves undergo cardiac contrast CT imaging and transthoracic echocardiography to evaluate structural and functional integrity of the aortic valves. Patients 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. | Drug: Warfarin<br>* Patients 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.<br>* Other names: Coumadin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patients with structural/functional abnormalities of bioprosthetic valves |  | 3 months |