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

Primary Purpose

Prosthetic Valve Thrombosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Warfarin
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthetic Valve Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre-existing bioprosthetic aortic valve

Arm 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 imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy.

Outcomes

Primary Outcome Measures

Frequency of patients with structural/functional abnormalities of bioprosthetic valves

Secondary Outcome Measures

Full Information

First Posted
December 4, 2014
Last Updated
April 18, 2023
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02318342
Brief Title
Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation
Acronym
RESOLVE
Official Title
Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Dysfunction With Multimodality Imaging and Its TrEatment With Anticoagulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Valve Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-existing bioprosthetic aortic valve
Arm Type
Experimental
Arm 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 imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention 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.
Primary Outcome Measure Information:
Title
Frequency of patients with structural/functional abnormalities of bioprosthetic valves
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Percentage of patients with resolution of bioprosthetic valve thrombotic lesions with anticoagulation
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarun Chakravarty, MD
Phone
3104233977
Email
tarunchakravarty@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj Makkar, MD
Organizational Affiliation
Cedars-Sinai Medical Center, Los Angeles, California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarun Chakravarty, MD
Phone
310-423-3977
Email
Tarun.Chakravarty@cshs.org
First Name & Middle Initial & Last Name & Degree
Raj R Makkar, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26436963
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.
Results Reference
background
PubMed Identifier
28330690
Citation
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.
Results Reference
background
PubMed Identifier
35680192
Citation
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.
Results Reference
derived
PubMed Identifier
33213747
Citation
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.
Results Reference
derived
PubMed Identifier
32192689
Citation
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.
Results Reference
derived

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

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