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

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Prosthetic Valve Thrombosis

Treatments: Drug: Warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT02318342

CSMC-37587

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 1 patient group

Pre-existing bioprosthetic aortic valve

Experimental group

Description:

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.

Treatment:

Drug: Warfarin