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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 : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Raj Makkar, Cedars-Sinai Medical Center

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 Vitamin K antagonists (warfarin) mediated anticoagulation therapy.

Condition or disease Intervention/treatment
Prosthetic Valve Thrombosis Drug: Warfarin

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 with Vitamin K antagonists (Warfarin) for 3 months with goal International Normalized Ratio (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. INR levels will be monitored and warfarin dose adjusted to maintain target INR 2-3.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
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 : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Frequency of patients with structural/functional abnormalities of bioprosthetic valves [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Percentage of patients with resolution of bioprosthetic valve thrombotic lesions with anticoagulation [ Time Frame: 3 months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

Phase 1

  • 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.

Phase 2

  • Appearance of thrombotic changes in the bioprosthetic valves

Exclusion Criteria:

  • Renal insufficiency (creatinine > 1.5 mg/dL)
  • Known allergy to iodinated contrast agents

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

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

Publications:
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     History of Changes
Other Study ID Numbers: CSMC-37587
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants