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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02318342
Other study ID # CSMC-37587
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date December 2026

Study information

Verified date April 2024
Source Cedars-Sinai Medical Center
Contact Tarun Chakravarty, MD
Phone 3104233977
Email tarunchakravarty@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jorgensen TH, Rami T, Israr S, Fontana G, de Knegt M, Fuchs A, Lyden P, Trento A, Bhatt DL, Leon MB, Makkar RR; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017 Jun 17;389(10087):2383-2392. doi: 10.1016/S0140-6736(17)30757-2. Epub 2017 Mar 19. — View Citation

Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of patients with resolution of bioprosthetic valve thrombotic lesions with anticoagulation 3 months
Primary Frequency of patients with structural/functional abnormalities of bioprosthetic valves 3 months
See also
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Completed NCT03943966 - In-vivo Thrombus Imaging With 18F-GP1, a Novel Platelet PET Radiotracer N/A
Completed NCT01451320 - Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis N/A