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NCT Number: NCT02318342

Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis 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 anticoagulation.

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Key information

Conditions

Prosthetic Valve Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Raj R Makkar, MD

PRINCIPAL_INVESTIGATOR

Tarun Chakravarty, MD

CONTACT

[email protected]

3104233977

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Coumadin

Primary outcomes

  1. Frequency of patients with structural/functional abnormalities of bioprosthetic valves

    Time frame: 3 months

Other outcomes

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

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Tarun Chakravarty, MD

CONTACT

[email protected]

3104233977

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Acronym: RESOLVE

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Dec 17, 2014
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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