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

Not Applicable

Recruiting

• Conditions: Prosthetic Valve Thrombosis
• Interventions: Drug: Warfarin

• Registration Number: NCT02318342
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-existing bioprosthetic aortic valve	Warfarin	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.

Primary Outcome Measures

Name	Time	Method
Frequency of patients with structural/functional abnormalities of bioprosthetic valves	3 months

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States