Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Evaluating and treating blood clots in heart valve replacements

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

Run by Cedars-Sinai Medical Center · NCT02318342 · Data updated 2026-11-12

This study is testing if advanced imaging can help find and treat blood clots in patients with bioprosthetic aortic valves to improve their health after surgery.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment3000 (estimated)
SponsorCedars-Sinai Medical Center
Academic / other
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedDecember 2014
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedJune 16, 2026
Trial IDNCT02318342 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who have received a bioprosthetic aortic valve at least 48 hours prior to enrollment.

Probably not a fit

Patients with renal insufficiency or known allergies to iodinated contrast agents may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the structural and functional integrity of bioprosthetic aortic valves using advanced imaging techniques, including cardiac contrast CT and transthoracic echocardiography. Patients who have undergone bioprosthetic valve replacement will be monitored for thrombotic changes, and those with abnormalities will receive anticoagulation therapy. Follow-up imaging will be conducted after three months to evaluate the effectiveness of the treatment. The goal is to confirm the resolution of thrombotic changes and improve patient outcomes.

Why it matters

Potential benefit: If successful, this study could enhance the management of prosthetic valve thrombosis, leading to better patient outcomes and reduced complications.

How similar studies have gone: Other studies have shown promise in managing prosthetic valve thrombosis with anticoagulation, indicating that this approach is supported by existing evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Cedars-Sinai Medical Center
    Los Angeles, California, United States
    Recruiting

Study contacts

  • Principal investigator: Raj Makkar, MD — Cedars-Sinai Medical Center, Los Angeles, California
  • Study coordinator: Tarun Chakravarty, MD
  • Email: tarunchakravarty@gmail.com
  • Phone: 3104233977

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.