Los Angeles, California 90048


Purpose:

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.


Study summary:

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


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


Study is Available At:


Original ID:

CSMC-37587


NCT ID:

NCT02318342


Secondary ID:


Study Acronym:

RESOLVE


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cedars-Sinai Medical Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

2000


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Raj Makkar, MD
Principal Investigator
Cedars-Sinai Medical Center, Los Angeles, California
Primary Contact:Tarun Chakravarty, MD
3104233977
tarunchakravarty@gmail.com

Study Dates

Start Date:December 2014
Completion Date:December 2021
Completion Type:Anticipated
Primary Completion Date:December 2019
Primary Completion Type:Anticipated
Verification Date:May 2019
Last Changed Date:May 6, 2019
First Received Date:December 4, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Frequency of patients with structural/functional abnormalities of bioprosthetic valves
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Warfarin
Description: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.
Arm Name:Pre-existing bioprosthetic aortic valve
Other Name:Coumadin

Study Arms

Study Arm Type:Experimental
Arm Name:Pre-existing bioprosthetic aortic valve
Description: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 i

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Cedars-Sinai Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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, Søndergaard 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.
PMID:26436963
Reference Type:Reference
Citation:Chakravarty T, Søndergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jørgensen 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.
PMID:28330690

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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