Aortic Valve StenosisSAVORYNCT02426307
Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT
An observational study of Aortic Valve Stenosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However, recent clinical experience has suggested that subclinical aortic valve bioprosthesis thrombosis may occur early after valve replacement. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- TAVR and SAVR
- Type of treatment
- Surgery or procedure
- How many people
- 274 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Apr 2030
- Phase
- Observational
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A random subset of patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) because of aortic valve stenosis.
Who may be able to join
- Successful TAVR or SAVR performed at Rigshospitalet, Copenhagen, Denmark
Who cannot join
- renal dysfunction (eGFR <25 ml/min)
- TAVR-in-TAVR
- Patients living in Greenland or the Faroe Islands
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, 2100
About this study
Official title: Subclinical Aortic Valve biOprosthesis thRombosis Assessed With 4D Computed tomographY Imaging
TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However, recent clinical experience has suggested that subclinical aortic valve bioprosthesis thrombosis may occur early after valve replacement. The frequency of this potentially ominous phenomenon on both transcatheter and surgical aortic valve bioprosthesis is unknown, as this condition is difficult to detect.
The recent development of cardiac 4D computed tomography imaging (4DCT) shows great promise for the evaluation of valve leaflet mobility and morphology.
The purpose of this study is in an observational design to assess the frequency of subclinical abnormal leaflet motion and morphology in patients treated with transcatheter or surgical aortic valve bioprosthesis. In addition, the 'natural evolution' of this phenomenon as well as its relation to medical treatment and MACCE will be assessed.
Read the detailed description
MATERIAL In the period from May 2014 to November 2015, a random subset of patients who underwent transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) were offered intensified post-procedural clinical and imaging follow-up. It is intended to examine a variety of implanted transcatheter heart valves (THV) as well as surgical aortic valve bioprosthesis.
METHODS:
Post-procedural clinical and imaging follow-up encompasses the following:
- Thoracic 4DCT scanning - with evaluation of leaflet morphology and leaflet motion
- Transthoracic echocardiography - with evaluation of peak aortic valve gradient, mean aortic valve gradient, aortic valve area/effective orifice area (cm2), paravalvular leakage, central aortic valve regurgitation, and left ventricular ejection fraction
- Clinical follow-up: improvement in New York Heart Association (NYHA) class dyspnea, and major adverse cardiac and cerebro-vascular events (MACCE)
- Registration of anti-coagulation/anti-thrombotic therapy following aortic valve replacement
All patients will receive the above-described post-procedural follow-up at two different time-points:
- The first follow-up contact will be planned 30 to 180 days after the TAVR or SAVR procedure. The medical treatment will not be changed based on the generated data.
- The second follow-up contact will be planned 120 to 180 days after the first follow-up contact (see above). This second follow-up offers the possibility to study the 'natural evolution' of this process. In those patients with an abnormal leaflet morphology and/or motion, a treatment with rivaroxaban 20mg daily will be initiated.
- Those patients initiated on rivaroxaban after the second follow-up will be called in for a third clinical and imaging follow-up, with focus on leaflet morphology and/or motion after rivaroxaban therapy. In case of persistent abnormal leaflet morphology and/or motion despite NOAC, a treatment with Marevan (INR 2-3) will be initiated.
- Those patients initiated on Marevan after the third follow-up will be called in for a fourth clinical and imaging follow-up contact.
- Conditions
- Aortic Valve Stenosis
- Being tested
- TAVR, SAVR
- Keywords
- Thrombosis, Cardiovascular disease, Oral anticoagulation, bioprosthesis, Multidetector Computed Tomography
- Medical subject headings
- Aortic Valve Stenosis, Thrombosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVRProcedure or surgery
TAVR: Transcatheter Aortic Valve Replacement
SAVRProcedure or surgery
SAVR: surgical Aortic Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement | TAVR: Portico (St Jude Medical), CoreValve (Medtronic), Lotus (Boston Scientific), Edwards Sapien 3 (Edwards LifeSciences), Receives: Procedure: TAVR | |
| Surgical aortic valve replacement | SAVR: Perimount (Edwards), Epic (St Jude Medical), Trifecta (St Jude Medical) Receives: Procedure: SAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology
Measured: At least 21 days post-procedure
Secondary outcomes (1)
Frequency of abnormal aortic valve bioprosthesis leaflet mobility and morphology
Measured: At least 21 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2018
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Klaus Fuglsang Kofoed, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Søndergaard, MD, Study director, Department of Cardiology, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426307
- Sponsor's protocol ID
- RIGHS.HJE.01
- Acronym
- SAVORY
- Status last verified
- Dec 2022
- First submitted
- 21 Apr 2015
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Thyregod HG, Steinbruchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrom T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Sondergaard L. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol. 2015 May 26;65(20):2184-94. doi: 10.1016/j.jacc.2015.03.014. Epub 2015 Mar 15.
PubMed 25787196Makkar 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 26436963Sondergaard L, De Backer O, Kofoed KF, Jilaihawi H, Fuchs A, Chakravarty T, Kashif M, Kazuno Y, Kawamori H, Maeno Y, Bieliauskas G, Guo H, Stone GW, Makkar R. Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J. 2017 Jul 21;38(28):2201-2207. doi: 10.1093/eurheartj/ehx369.
PubMed 28838044
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Aortic Valve biOprosthesis thRombosis Assessed With 4D Computed tomographY Imaging
- ClinicalTrials.gov ID
- NCT02426307
- Acronym / sponsor ID
- SAVORY / RIGHS.HJE.01
- Conditions
- Aortic Valve Stenosis
- Keywords
- Thrombosis, Cardiovascular disease, Oral anticoagulation, bioprosthesis, Multidetector Computed Tomography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- Apr 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Apr 2030 (estimated)
- First posted
- 24 Apr 2015 (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.
TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However, recent clinical experience has suggested that subclinical aortic valve bioprosthesis thrombosis may occur early after valve replacement. The frequency of this potentially ominous phenomenon on both transcatheter and surgical aortic valve bioprosthesis is unknown, as this condition is difficult to detect.
The recent development of cardiac 4D computed tomography imaging (4DCT) shows great promise for the evaluation of valve leaflet mobility and morphology.
The purpose of this study is in an observational design to assess the frequency of subclinical abnormal leaflet motion and morphology in patients treated with transcatheter or surgical aortic valve bioprosthesis. In addition, the 'natural evolution' of this phenomenon as well as its relation to medical treatment and MACCE will be assessed.
Detailed description
MATERIAL In the period from May 2014 to November 2015, a random subset of patients who underwent transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) were offered intensified post-procedural clinical and imaging follow-up. It is intended to examine a variety of implanted transcatheter heart valves (THV) as well as surgical aortic valve bioprosthesis.
METHODS:
Post-procedural clinical and imaging follow-up encompasses the following:
- Thoracic 4DCT scanning - with evaluation of leaflet morphology and leaflet motion
- Transthoracic echocardiography - with evaluation of peak aortic valve gradient, mean aortic valve gradient, aortic valve area/effective orifice area (cm2), paravalvular leakage, central aortic valve regurgitation, and left ventricular ejection fraction
- Clinical follow-up: improvement in New York Heart Association (NYHA) class dyspnea, and major adverse cardiac and cerebro-vascular events (MACCE)
- Registration of anti-coagulation/anti-thrombotic therapy following aortic valve replacement
All patients will receive the above-described post-procedural follow-up at two different time-points:
- The first follow-up contact will be planned 30 to 180 days after the TAVR or SAVR procedure. The medical treatment will not be changed based on the generated data.
- The second follow-up contact will be planned 120 to 180 days after the first follow-up contact (see above). This second follow-up offers the possibility to study the 'natural evolution' of this process. In those patients with an abnormal leaflet morphology and/or motion, a treatment with rivaroxaban 20mg daily will be initiated.
- Those patients initiated on rivaroxaban after the second follow-up will be called in for a third clinical and imaging follow-up, with focus on leaflet morphology and/or motion after rivaroxaban therapy. In case of persistent abnormal leaflet morphology and/or motion despite NOAC, a treatment with Marevan (INR 2-3) will be initiated.
- Those patients initiated on Marevan after the third follow-up will be called in for a fourth clinical and imaging follow-up contact.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Replacement | – | Procedure: TAVRTAVR: Portico (St Jude Medical), CoreValve (Medtronic), Lotus (Boston Scientific), Edwards Sapien 3 (Edwards LifeSciences), |
| Surgical aortic valve replacement | – | Procedure: SAVRSAVR: Perimount (Edwards), Epic (St Jude Medical), Trifecta (St Jude Medical) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A random subset of patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) because of aortic valve stenosis.
Key inclusion criteria (1 listed)
- Successful TAVR or SAVR performed at Rigshospitalet, Copenhagen, Denmark
Key exclusion criteria (3 listed)
- renal dysfunction (eGFR <25 ml/min)
- TAVR-in-TAVR
- Patients living in Greenland or the Faroe Islands
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 |
|---|---|---|
| TAVRTAVR: Transcatheter Aortic Valve Replacement | Procedure or surgery | Transcatheter Aortic Valve Replacement |
| SAVRSAVR: surgical Aortic Valve Replacement | Procedure or surgery | Surgical aortic valve replacement |
Primary outcome
Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology
Time frame: At least 21 days post-procedure
1 secondary outcome
Frequency of abnormal aortic valve bioprosthesis leaflet mobility and morphology
Time frame: At least 21 days post-procedure
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 12 Dec 2022.
- Background: PubMed 25787196Thyregod HG, Steinbruchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrom T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Sondergaard L. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol. 2015 May 26;65(20):2184-94. doi: 10.1016/j.jacc.2015.03.014. Epub 2015 Mar 15.
- Results publication: 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 28838044Sondergaard L, De Backer O, Kofoed KF, Jilaihawi H, Fuchs A, Chakravarty T, Kashif M, Kazuno Y, Kawamori H, Maeno Y, Bieliauskas G, Guo H, Stone GW, Makkar R. Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J. 2017 Jul 21;38(28):2201-2207. doi: 10.1093/eurheartj/ehx369.
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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. This study is not recruiting at the moment.
Lars Søndergaard, MD study director
Department of Cardiology, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2022. 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 Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology (time frame: At least 21 days post-procedure). 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 NCT02426307, which also lists 3 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 12 Dec 2022.