Prosthetic Cardiac Valve ThrombosisPhase 4RETORICNCT02826200
Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography (RETORIC)
A Phase 4 study testing Acenocoumarol in people with Prosthetic Cardiac Valve Thrombosis and Cerebrovascular Accident, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence and independent predictors of reduced leaflet motion and valve thrombosis after TAVI procedure using multimodality imaging strategy comprising cardiac CT, transesophageal echocardiography (TEE) and transthoracic echocardiography… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Prosthetic Cardiac Valve Thrombosis, Cerebrovascular Accident, Prosthetic Valve Malfunction
- What is being tested?
- Acenocoumarol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHungary
- Study dates
- Jul 2016to Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TAVI procedure
- Signed ethics committee-approved informed consent form
Who cannot join
- Age under 18 years
- Patients for whom multidetector-row computed tomography is contraindicated per institutional standard of care (History of severe and/or anaphylactic contrast reaction, severe renal insufficiency, inability to cooperate with scan acquisition and/or breathhold instructions)
- Patients diagnosed with infective endocarditis since TAVI procedure
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Heart and Vascular Center, Semmelweis University
Budapest, 1122
Pál Maurovich-Horvat, MD PhD MPH, +36206632485, p.maurovich-horvat@cirg.hu
Astrid Apor, MD, +36208258004, aporastrid@gmail.com
About this study
Official title: Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence and independent predictors of reduced leaflet motion and valve thrombosis after TAVI procedure using multimodality imaging strategy comprising cardiac CT, transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced leaflet motion and/or thrombosis when compared with those with normal leaflet function. In addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy.
The primary outcome of the nested randomized trial will be the presence of reduced leaflet motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of ischemic changes in brain demonstrated by MRI.
Read the detailed description
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis in patients non-eligible for surgical aortic valve replacement. Prosthetic valve thrombosis is defined as a thrombus that is attached to any part of the prosthesis, and is not caused by infection. This may result in valve dysfunction and/or thromboembolisation. Most patients with prosthetic valve thrombosis are asymptomatic, whereas some patients present with stroke or transient ischemic attack (TIA). Obstructive prosthetic valve thrombosis may lead to overt congestive heart failure.
Currently, there is no strict guideline recommendation regarding therapeutic anticoagulation after TAVI. Per institutional protocol dual antiplatelet therapy is used during the first 6 months after THV implantation and single antiplatelet therapy is used after after 6 months.
Diagnosing transcatheter heart valve (THV) thrombosis is of clinical importance even in asymptomatic patients, because it may lead to thromboembolism and can cause THV dysfunction. Therefore, early diagnosis and treatment may prevent future TIA or stroke and THV dysfunction. Current standard clinical practice and guidelines are inconsistent regarding the antithrombotic treatment of patients who underwent TAVI procedure. Accordingly, determining the true incidence and potential causative factors of THV thrombosis is of great importance and would facilitate further investigations and large clinical trials in order to develop optimal antithrombotic treatment of patients following TAVI procedure.
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence and independent predictors of reduced leaflet motion and valve thrombosis after TAVI procedure using multimodality imaging strategy comprising cardiac CT, transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will assess the incidence of stroke and TIA in those with reduced leaflet motion and thrombosis when compared with those with normal leaflet function. In addition we will randomise patients with reduced leaflet motion to unchanged standard therapy versus single antiplatelet plus oral anticoagulation therapy. The primary outcome of this nested randomized trial will be the presence of novel ischemic lesions in brain demonstrated by MRI.
Findings of the RETORIC study may alter current post-TAVI diagnostic work up and treatment algorithm regarding anticoagulant and antiplatelet therapies.
In total 200 patients who underwent or are undergoing TAVI procedure will be included into the RETORIC study. The institutional standard of care post-TAVI antithrombotic medication consists of six months dual antiplatelet treatment with clopidogrel and aspirin followed by lifelong aspirin therapy.
Currently, the TAVI procedure number at our institution is approximately 80 patients/year. Therefore, to reach our enrolment goal of 200 patients, subjects will be enrolled from two cohorts.
Cohort A: Patients who underwent TAVI procedure in the past will be selected from the Semmelweis TAVI Registry. For this cohort a median TAVI-to-CT time will be calculated.
Cohort B: Patients undergoing TAVI procedure will be enrolled consecutively. In this group the imaging will be performed 3 months after the prosthesis implantation in every patient.
Four-dimensional cardiac CT, TTE and brain MRI data will be obtained in all patients. In case the cardiac CT identifies reduced leaflet motion or THV thrombosis TEE exam will be performed even in asymptomatic patients and patients will enter the randomized control trial. Patients will be randomized into two groups:
Group 1, standard therapy plus oral anticoagulant therapy; Group 2, standard therapy. After 4 months patients will undergo four-dimensional cardiac CT, TTE and brain MRI.
The primary outcome of the randomized trial will be the presence of reduced leaflet motion/valve thrombosis, secondary outcome will be the presence of ischemic lesions on brain MRI images.
- Conditions
- Prosthetic Cardiac Valve Thrombosis, Cerebrovascular Accident, Prosthetic Valve Malfunction
- Being tested
- Acenocoumarol, Standard of care
- Keywords
- Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Prosthetic Cardiac Valve Thrombosis, Cerebrovascular Accident, Prosthetic Valve Malfunction, Four-dimensional volume rendered cardiac CT, Transesophageal echocardiography, Transthoracic echocardiography, Brain MRI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcenocoumarolDrug
Standard of care plus oral anticoagulant therapy (acenocoumarol)
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (SOC+OAT) | Experimental | Patients with reduced leaflet motion or with prosthetic heart valve thrombosis receiving single antiplatelet therapy plus oral anticoagulant therapy. Receives: Drug: Acenocoumarol; Other: Standard of care |
| Group 2 (SOC) | Active comparator | Patients with reduced leaflet motion or with prosthetic heart valve thrombosis receiving standard of care therapy. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced leaflet motion and/or valve thrombosis
Measured: 4 months
Secondary outcomes (1)
Presence of ischemic brain lesions
Presence of ischemic brain lesions demonstrated by MRI
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prosthetic Cardiac Valve ThrombosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béla Merkely, MD, PhD, DSc, Principal investigator, Semmelweis University Heart and Vascular CenterPál Maurovich-Horvat, MD, PhD, MPH, Principal investigator, Semmelweis University Heart and Vascular CenterRonak Rajani, MD MRCP BM, Study chair, Guy's and St Thomas' NHS Foundation Trust, Kings College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826200
- Sponsor's protocol ID
- The RETORIC study
- Acronym
- RETORIC
- Status last verified
- Jan 2017
- First submitted
- 5 Jul 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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 26436963Apor A, Bartykowszki A, Szilveszter B, Varga A, Suhai FI, Manouras A, Molnar L, Jermendy AL, Panajotu A, Turani MF, Papp R, Karady J, Kolossvary M, Kovats T, Maurovich-Horvat P, Merkely B, Nagy AI. Subclinical leaflet thrombosis after transcatheter aortic valve implantation is associated with silent brain injury on brain magnetic resonance imaging. Eur Heart J Cardiovasc Imaging. 2022 Nov 17;23(12):1584-1595. doi: 10.1093/ehjci/jeac191.
PubMed 36168113Varga A, Gyebnar G, Suhai FI, Nagy AI, Kozak LR, Poka CA, Turani MF, Borzsak S, Apor A, Bartykowszki A, Szilveszter B, Kolossvary M, Maurovich-Horvat P, Merkely B. Microstructural alterations measured by diffusion tensor imaging following transcatheter aortic valve replacement and their association with cerebral ischemic injury and cognitive function - a prospective study. Neuroradiology. 2022 Dec;64(12):2343-2356. doi: 10.1007/s00234-022-03017-5. Epub 2022 Aug 1.
PubMed 35915181Vattay B, Nagy AI, Apor A, Kolossvary M, Manouras A, Vecsey-Nagy M, Molnar L, Boussoussou M, Bartykowszki A, Jermendy AL, Kovats T, Zsarnoczay E, Maurovich-Horvat P, Merkely B, Szilveszter B. The Predictive Value of Left Atrial Strain Following Transcatheter Aortic Valve Implantation on Anatomical and Functional Reverse Remodeling in a Multi-Modality Study. Front Cardiovasc Med. 2022 Apr 25;9:841658. doi: 10.3389/fcvm.2022.841658. eCollection 2022.
PubMed 35548439Karady J, Apor A, Nagy AI, Kolossvary M, Bartykowszki A, Szilveszter B, Simon J, Molnar L, Jermendy AL, Panajotu A, Suhai FI, Varga A, Rajani R, Maurovich-Horvat P, Merkely B. Quantification of hypo-attenuated leaflet thickening after transcatheter aortic valve implantation: clinical relevance of hypo-attenuated leaflet thickening volume. Eur Heart J Cardiovasc Imaging. 2020 Dec 1;21(12):1395-1404. doi: 10.1093/ehjci/jeaa184.
PubMed 32756984
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography
- ClinicalTrials.gov ID
- NCT02826200
- Acronym / sponsor ID
- RETORIC / The RETORIC study
- Conditions
- Prosthetic Cardiac Valve Thrombosis, Cerebrovascular Accident, Prosthetic Valve Malfunction
- Keywords
- Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Prosthetic Cardiac Valve Thrombosis, Cerebrovascular Accident, Prosthetic Valve Malfunction, Four-dimensional volume rendered cardiac CT, Transesophageal echocardiography, Transthoracic echocardiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 7 Jul 2016 (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.
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence and independent predictors of reduced leaflet motion and valve thrombosis after TAVI procedure using multimodality imaging strategy comprising cardiac CT, transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced leaflet motion and/or thrombosis when compared with those with normal leaflet function. In addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy.
The primary outcome of the nested randomized trial will be the presence of reduced leaflet motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of ischemic changes in brain demonstrated by MRI.
Detailed description
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis in patients non-eligible for surgical aortic valve replacement. Prosthetic valve thrombosis is defined as a thrombus that is attached to any part of the prosthesis, and is not caused by infection. This may result in valve dysfunction and/or thromboembolisation. Most patients with prosthetic valve thrombosis are asymptomatic, whereas some patients present with stroke or transient ischemic attack (TIA). Obstructive prosthetic valve thrombosis may lead to overt congestive heart failure.
Currently, there is no strict guideline recommendation regarding therapeutic anticoagulation after TAVI. Per institutional protocol dual antiplatelet therapy is used during the first 6 months after THV implantation and single antiplatelet therapy is used after after 6 months.
Diagnosing transcatheter heart valve (THV) thrombosis is of clinical importance even in asymptomatic patients, because it may lead to thromboembolism and can cause THV dysfunction. Therefore, early diagnosis and treatment may prevent future TIA or stroke and THV dysfunction. Current standard clinical practice and guidelines are inconsistent regarding the antithrombotic treatment of patients who underwent TAVI procedure. Accordingly, determining the true incidence and potential causative factors of THV thrombosis is of great importance and would facilitate further investigations and large clinical trials in order to develop optimal antithrombotic treatment of patients following TAVI procedure.
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence and independent predictors of reduced leaflet motion and valve thrombosis after TAVI procedure using multimodality imaging strategy comprising cardiac CT, transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will assess the incidence of stroke and TIA in those with reduced leaflet motion and thrombosis when compared with those with normal leaflet function. In addition we will randomise patients with reduced leaflet motion to unchanged standard therapy versus single antiplatelet plus oral anticoagulation therapy. The primary outcome of this nested randomized trial will be the presence of novel ischemic lesions in brain demonstrated by MRI.
Findings of the RETORIC study may alter current post-TAVI diagnostic work up and treatment algorithm regarding anticoagulant and antiplatelet therapies.
In total 200 patients who underwent or are undergoing TAVI procedure will be included into the RETORIC study. The institutional standard of care post-TAVI antithrombotic medication consists of six months dual antiplatelet treatment with clopidogrel and aspirin followed by lifelong aspirin therapy.
Currently, the TAVI procedure number at our institution is approximately 80 patients/year. Therefore, to reach our enrolment goal of 200 patients, subjects will be enrolled from two cohorts.
Cohort A: Patients who underwent TAVI procedure in the past will be selected from the Semmelweis TAVI Registry. For this cohort a median TAVI-to-CT time will be calculated.
Cohort B: Patients undergoing TAVI procedure will be enrolled consecutively. In this group the imaging will be performed 3 months after the prosthesis implantation in every patient.
Four-dimensional cardiac CT, TTE and brain MRI data will be obtained in all patients. In case the cardiac CT identifies reduced leaflet motion or THV thrombosis TEE exam will be performed even in asymptomatic patients and patients will enter the randomized control trial. Patients will be randomized into two groups:
Group 1, standard therapy plus oral anticoagulant therapy; Group 2, standard therapy. After 4 months patients will undergo four-dimensional cardiac CT, TTE and brain MRI.
The primary outcome of the randomized trial will be the presence of reduced leaflet motion/valve thrombosis, secondary outcome will be the presence of ischemic lesions on brain MRI images.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (SOC+OAT) | Experimental | Drug: Acenocoumarol, Other: Standard of carePatients with reduced leaflet motion or with prosthetic heart valve thrombosis receiving single antiplatelet therapy plus oral anticoagulant therapy. |
| Group 2 (SOC) | Active comparator | Other: Standard of carePatients with reduced leaflet motion or with prosthetic heart valve thrombosis receiving standard of care therapy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- TAVI procedure
- Signed ethics committee-approved informed consent form
Key exclusion criteria (3 listed)
- Age under 18 years
- Patients for whom multidetector-row computed tomography is contraindicated per institutional standard of care (History of severe and/or anaphylactic contrast reaction, severe renal insufficiency, inability to cooperate with scan acquisition and/or breathhold instructions)
- Patients diagnosed with infective endocarditis since TAVI procedure
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 |
|---|---|---|
| AcenocoumarolStandard of care plus oral anticoagulant therapy (acenocoumarol) | Drug | Group 1 (SOC+OAT) |
| Standard of careStandard of care | Other | Group 1 (SOC+OAT), Group 2 (SOC) |
Primary outcome
Reduced leaflet motion and/or valve thrombosis
Time frame: 4 months
1 secondary outcome
Presence of ischemic brain lesions
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- 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.
- Derived from this study: PubMed 36168113Apor A, Bartykowszki A, Szilveszter B, Varga A, Suhai FI, Manouras A, Molnar L, Jermendy AL, Panajotu A, Turani MF, Papp R, Karady J, Kolossvary M, Kovats T, Maurovich-Horvat P, Merkely B, Nagy AI. Subclinical leaflet thrombosis after transcatheter aortic valve implantation is associated with silent brain injury on brain magnetic resonance imaging. Eur Heart J Cardiovasc Imaging. 2022 Nov 17;23(12):1584-1595. doi: 10.1093/ehjci/jeac191.
- Derived from this study: PubMed 35915181Varga A, Gyebnar G, Suhai FI, Nagy AI, Kozak LR, Poka CA, Turani MF, Borzsak S, Apor A, Bartykowszki A, Szilveszter B, Kolossvary M, Maurovich-Horvat P, Merkely B. Microstructural alterations measured by diffusion tensor imaging following transcatheter aortic valve replacement and their association with cerebral ischemic injury and cognitive function - a prospective study. Neuroradiology. 2022 Dec;64(12):2343-2356. doi: 10.1007/s00234-022-03017-5. Epub 2022 Aug 1.
- Derived from this study: PubMed 35548439Vattay B, Nagy AI, Apor A, Kolossvary M, Manouras A, Vecsey-Nagy M, Molnar L, Boussoussou M, Bartykowszki A, Jermendy AL, Kovats T, Zsarnoczay E, Maurovich-Horvat P, Merkely B, Szilveszter B. The Predictive Value of Left Atrial Strain Following Transcatheter Aortic Valve Implantation on Anatomical and Functional Reverse Remodeling in a Multi-Modality Study. Front Cardiovasc Med. 2022 Apr 25;9:841658. doi: 10.3389/fcvm.2022.841658. eCollection 2022.
- Derived from this study: PubMed 32756984Karady J, Apor A, Nagy AI, Kolossvary M, Bartykowszki A, Szilveszter B, Simon J, Molnar L, Jermendy AL, Panajotu A, Suhai FI, Varga A, Rajani R, Maurovich-Horvat P, Merkely B. Quantification of hypo-attenuated leaflet thickening after transcatheter aortic valve implantation: clinical relevance of hypo-attenuated leaflet thickening volume. Eur Heart J Cardiovasc Imaging. 2020 Dec 1;21(12):1395-1404. doi: 10.1093/ehjci/jeaa184.
- Individual participant dataSharing planned: No
Related trials for Prosthetic Cardiac Valve Thrombosis
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REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
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. This study is not recruiting at the moment.
Béla Merkely, MD, PhD, DSc principal investigator
Semmelweis University Heart and Vascular Center
Pál Maurovich-Horvat, MD, PhD, MPH principal investigator
Semmelweis University Heart and Vascular Center
Ronak Rajani, MD MRCP BM study chair
Guy's and St Thomas' NHS Foundation Trust, Kings College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acenocoumarol in people with Prosthetic Cardiac Valve Thrombosis and Cerebrovascular Accident, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2017. 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 Hungary. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pál Maurovich-Horvat, MD, PhD, MPH (+36206632485, p.maurovich-horvat@cirg.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced leaflet motion and/or valve thrombosis (time frame: 4 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 NCT02826200, which also lists 5 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 18 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.