Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation
Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Dysfunction With Multimodality Imaging and Its TrEatment With Anticoagulation
Cedars-Sinai Medical Center
3,000 participants
Dec 1, 2014
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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 Criteria2
- Renal insufficiency (creatinine > 1.5 mg/dL)
- Known allergy to iodinated contrast agents
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02318342