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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Renal insufficiency (creatinine > 1.5 mg/dL)

Known allergy to iodinated contrast agents

Trial design

Design model

Single group

Treatments tested in this trial

  • Warfarin

    Drug

    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 groups

3,000 Participants
are divided into 1 treatment group
Group A: Pre-existing bioprosthetic aortic valveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of patients with structural/functional abnormalities of bioprosthetic valves

Time frame
3 months

Secondary outcomes

Other outcomes

1

Percentage of patients with resolution of bioprosthetic valve thrombotic lesions with anticoagulation

Time frame
3 months

Sponsors and contacts

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