NCT02318342

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Dec 2014Dec 2027

Study Start

First participant enrolled

December 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

12 years

First QC Date

December 4, 2014

Last Update Submit

June 2, 2025

Conditions

Prosthetic Valve Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Frequency of patients with structural/functional abnormalities of bioprosthetic valves

    3 months

Other Outcomes (1)

  • Percentage of patients with resolution of bioprosthetic valve thrombotic lesions with anticoagulation

    3 months

Study Arms (1)

Pre-existing bioprosthetic aortic valve

EXPERIMENTAL

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

Interventions

WarfarinDRUG

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.

Also known as: Coumadin
Pre-existing bioprosthetic aortic valve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (7)

  • 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.

    PMID: 26436963BACKGROUND

  • 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.

    PMID: 28330690BACKGROUND

  • Nagasaka T, Patel V, Suruga K, Guo Y, Koren O, Shechter A, Friedman M, Patel D, Chakravarty T, Cheng W, Gupta A, Ishii H, Jilaihawi H, Nakamura M, Makkar RR. Prognostic implications and predictive factors of subclinical leaflet thrombosis following valve-in-valve transcatheter aortic valve implantation. EuroIntervention. 2025 May 5;21(9):e482-e492. doi: 10.4244/EIJ-D-24-00711.

    PMID: 40325986DERIVED

  • Nagasaka T, Patel V, Shechter A, Suruga K, Koren O, Chakravarty T, Cheng W, Ishii H, Jilaihawi H, Nakamura M, Makkar RR. Impact of Balloon-Expandable TAVR Valve Deformation and Calcium Distribution on Outcomes in Bicuspid Aortic Valve. JACC Cardiovasc Interv. 2024 Sep 9;17(17):2023-2037. doi: 10.1016/j.jcin.2024.07.018.

    PMID: 39260960DERIVED

  • 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.

    PMID: 35680192DERIVED

  • 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.

    PMID: 33213747DERIVED

  • 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.

    PMID: 32192689DERIVED

MeSH Terms

Interventions

Warfarin

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Raj Makkar, MD

    Cedars-Sinai Medical Center, Los Angeles, California

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarun Chakravarty, MD

CONTACT

3104233977tarunchakravarty@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Cedars-Sinai Heart Institute; Professor of Medicine, University of California, Los Angeles; Director, Cardiac Catheterization Laboratories and Intervention Center

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 17, 2014

Study Start

December 1, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

June 5, 2025

Record last verified: 2025-06

Locations

US(1)