Prosthetic Valve ThrombosisRESOLVENCT02318342
Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation
A study testing Warfarin in people with Prosthetic Valve Thrombosis, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Valve Thrombosis
- What is being tested?
- Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Renal insufficiency (creatinine > 1.5 mg/dL)
- Known allergy to iodinated contrast agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Tarun Chakravarty, MD, 3104233977, Tarun.Chakravarty@cshs.org
Raj R Makkar, MD
About this study
Official title: Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Dysfunction With Multimodality Imaging and Its TrEatment With Anticoagulation
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.
Read the 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
- Conditions
- Prosthetic Valve Thrombosis
- Being tested
- Warfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called Coumadin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients with structural/functional abnormalities of bioprosthetic valves
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prosthetic Valve ThrombosisStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Makkar, Cedars-Sinai Medical Center
- Investigators
- Raj Makkar, MD, Principal investigator, Cedars-Sinai Medical Center, Los Angeles, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318342
- Sponsor's protocol ID
- CSMC-37587
- Acronym
- RESOLVE
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2014
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26436963Chakravarty 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.
PubMed 28330690Nagasaka 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.
PubMed 40325986Nagasaka 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.
PubMed 39260960Raschpichler 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.
PubMed 35680192Ochiai 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.
PubMed 33213747Ochiai 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.
PubMed 32192689
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Dysfunction With Multimodality Imaging and Its TrEatment With Anticoagulation
- ClinicalTrials.gov ID
- NCT02318342
- Acronym / sponsor ID
- RESOLVE / CSMC-37587
- Conditions
- Prosthetic Valve Thrombosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-existing bioprosthetic aortic valve | Experimental | Drug: WarfarinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Renal insufficiency (creatinine > 1.5 mg/dL)
- Known allergy to iodinated contrast agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WarfarinAlso: CoumadinPatients 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 | Pre-existing bioprosthetic aortic valve |
Primary outcome
Frequency of patients with structural/functional abnormalities of bioprosthetic valves
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 26436963Makkar 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.
- Background: PubMed 28330690Chakravarty 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.
- Derived from this study: PubMed 40325986Nagasaka 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.
- Derived from this study: PubMed 39260960Nagasaka 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.
- Derived from this study: PubMed 35680192Raschpichler 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.
- Derived from this study: PubMed 33213747Ochiai 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.
- Derived from this study: PubMed 32192689Ochiai 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raj Makkar, MD principal investigator
Cedars-Sinai Medical Center, Los Angeles, California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin in people with Prosthetic Valve Thrombosis, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarun Chakravarty, MD (3104233977, tarunchakravarty@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of patients with structural/functional abnormalities of bioprosthetic valves (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02318342, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.