Los Angeles, California 90048


Purpose:

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 Vitamin K antagonists (warfarin) mediated anticoagulation therapy.


Study summary:

Patients with a history of SAVR or TAVR with bioprosthetic aortic valves 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 TAVR/SAVR. Patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy with Vitamin K antagonists (Warfarin) for 3 months with goal International Normalized Ratio (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. INR levels will be monitored and warfarin dose adjusted to maintain target INR 2-3.


Criteria:

Inclusion Criteria: Phase 1 - 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. Phase 2 - Appearance of thrombotic changes in the bioprosthetic valves Exclusion Criteria: - Renal insufficiency (creatinine > 1.5 mg/dL) - Known allergy to iodinated contrast agents


NCT ID:

NCT02318342


Primary Contact:

Principal Investigator
Raj Makkar, MD
Cedars-Sinai Medical Center, Los Angeles, California

Tarun Chakravarty, MD
Phone: 3104233977
Email: tarunchakravarty@gmail.com


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90048
United States

Tarun Chakravarty, MD
Phone: 310-423-3977
Email: Tarun.Chakravarty@cshs.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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