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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/31/2018
Start Date:December 2014
End Date:December 2021
Contact:Tarun Chakravarty, MD
Email:tarunchakravarty@gmail.com
Phone:3104233977

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

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.

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 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.

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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Raj R Makkar, MD
Phone: 310-423-3977
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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