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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2021
  • participants needed
    2000
  • sponsor
    Cedars-Sinai Medical Center
Updated on 26 January 2021

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.

Description

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

Details
Condition Prosthetic Valve Thrombosis
Treatment Warfarin
Clinical Study IdentifierNCT02318342
SponsorCedars-Sinai Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Prosthetic Valve Thrombosis?
Do you have any of these conditions: Do you have Prosthetic Valve Thrombosis??
Do you have any of these conditions: Do you have Prosthetic Valve Thrombosis??
Do you have any of these conditions: Do you have Prosthetic Valve Thrombosis??
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
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