Recruiting

Anticoagulation

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT02318342

Conditions

Prosthetic Valve Thrombosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Warfarin

Study Details

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.

Conditions

Prosthetic Valve Thrombosis

Study ID

NCT02318342

Start date

Dec, 2014

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

3000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pre-existing bioprosthetic aortic valve

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.

Interventions

Warfarin

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 measure

  • Frequency of patients with structural/functional abnormalities of bioprosthetic valves [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Tarun Chakravarty, MD

3104233977tarunchakravarty@gmail.com

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Tarun Chakravarty, MD

3104233977Tarun.Chakravarty@cshs.org

Principal Investigator:

Raj R Makkar, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-06-16.