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

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ClinicalTrials.gov Identifier: NCT02318342

Recruitment Status : Recruiting

First Posted : December 17, 2014

Last Update Posted : April 19, 2023

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Sponsor:

Information provided by (Responsible Party):

Raj Makkar, Cedars-Sinai Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prosthetic Valve Thrombosis	Drug: Warfarin	Not Applicable

Detailed 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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	3000 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Dysfunction With Multimodality Imaging and Its TrEatment With Anticoagulation
Study Start Date :	December 2014
Estimated Primary Completion Date :	October 2024
Estimated Study Completion Date :	December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots Blood Thinners

Drug Information available for: Warfarin Warfarin sodium

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	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. Other Name: Coumadin

Arm

Intervention/treatment

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.

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.

Other Name: Coumadin

Outcome Measures

Primary Outcome Measures :

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

Other Outcome Measures:

Percentage of patients with resolution of bioprosthetic valve thrombotic lesions with anticoagulation [ Time Frame: 3 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318342

Contacts

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Contact: Tarun Chakravarty, MD	3104233977	tarunchakravarty@gmail.com

Locations

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United States, California
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Contact: Tarun Chakravarty, MD 310-423-3977 Tarun.Chakravarty@cshs.org
Principal Investigator: Raj R Makkar, MD

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

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Principal Investigator:	Raj Makkar, MD	Cedars-Sinai Medical Center, Los Angeles, California

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Raschpichler M, Flint N, Yoon SH, Kaewkes D, Patel C, Singh C, Patel V, Kashif M, Borger MA, Chakravarty T, Makkar R. Commissural Alignment After Balloon-Expandable Transcatheter Aortic Valve Replacement Is Associated With Improved Hemodynamic Outcomes. JACC Cardiovasc Interv. 2022 Jun 13;15(11):1126-1136. doi: 10.1016/j.jcin.2022.04.006.

Ochiai T, Oakley L, Sekhon N, Komatsu I, Flint N, Kaewkes D, Yoon SH, Raschpichler M, Patel V, Tiwana R, Enta Y, Mahani S, Kim Y, Stegic J, Chakravarty T, Nakamura M, Cheng W, Makkar R. Risk of Coronary Obstruction Due to Sinus Sequestration in Redo Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Nov 23;13(22):2617-2627. doi: 10.1016/j.jcin.2020.09.022.

Ochiai T, Chakravarty T, Yoon SH, Kaewkes D, Flint N, Patel V, Mahani S, Tiwana R, Sekhon N, Nakamura M, Cheng W, Makkar R. Coronary Access After TAVR. JACC Cardiovasc Interv. 2020 Mar 23;13(6):693-705. doi: 10.1016/j.jcin.2020.01.216.

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Responsible Party:	Raj Makkar, Associate Director, Cedars-Sinai Heart Institute; Professor of Medicine, University of California, Los Angeles; Director, Cardiac Catheterization Laboratories and Intervention Center, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT02318342
Other Study ID Numbers:	CSMC-37587
First Posted:	December 17, 2014 Key Record Dates
Last Update Posted:	April 19, 2023
Last Verified:	February 2023

Additional relevant MeSH terms:

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Thrombosis Embolism and Thrombosis Vascular Diseases	Cardiovascular Diseases Warfarin Anticoagulants

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