Aortic Valve StenosisNCT03074838
Inflammatory Response to Aortic Valve Replacement
A study testing Transarterial aortic valve implantation - TAVI and Surgical aortic valve replacement - SAVR in people with Aortic Valve Stenosis, run by Oslo University Hospital.
Trial summary
A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transarterial aortic valve implantation - TAVI and Surgical aortic valve replacement - SAVR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2012to 31 Dec 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients eligible for aortic valve replacement without need for concurrent surgery
Who cannot join
- known inflammatory disease and anti-inflammatory treatment
About this study
Official title: Reduced Inflammatory Response Using Transcatheter Aortic Valve Replacement as Compared to Conventional Surgery
A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.
Read the detailed description
18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (TAVI) (9 transfemoral and 9 transaortic) are included.
A plasma sample is obtained at defined timepoints before, during and after surgery. At each time points the following biomarkers are analyzed:Concentrations of the complement activation products C3bc and the terminal C5b-9 complement complex (TCC), the neutrophil release product myeloperoxidase (MPO), the cytokines IL-6, eotaxin, MCP-1 and MIP-1β (12). As marker of a myocardial cellular injury troponin T levels will be analyzed. The following clinical outcomes will also be monitored: Death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction.
A dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. The registry will be deleted after completion of the study.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transarterial aortic valve implantation - TAVI, Surgical aortic valve replacement - SAVR
- Keywords
- Cardiac surgery, TAVI
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial aortic valve implantation - TAVIProcedure or surgery
After insertion of a guidewire, either through the femoral artery or through the ascending aorta, the aortic ostium is dilated by a balloon and the valve is introduced through a catheter and expanded in the ostium.
Surgical aortic valve replacement - SAVRProcedure or surgery
The patient is operated through a sternotomy and coupled to a heart lung machine. The aorta is opened and the native valve excised. Then a biological artificial heart valve is sutured in place.
| Study group | Role | What they receive |
|---|---|---|
| Transarterial aortic valve implantation | Experimental | Patients that are treated by trans arterial valve implantation (TAVI) Receives: Procedure: Transarterial aortic valve implantation - TAVI |
| Surgical aortic valve replacement | Active comparator | Patients that are treated by surgical aortic valve replacement (SAVR) Receives: Procedure: Surgical aortic valve replacement - SAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of several inflammatory markers measured through repeated blood samples
The total generation of several inflammatory markers is compared between the groups
Measured: 24 hours
Secondary outcomes (2)
Blood loss
ml blood loss compared between the groups
Measured: 24 hrs
Blood transfusion
Number of blood Products tranfused after the procedure
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 Dec 2012
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Oslo University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A case Control study were patients undergoing two surgical Methods for aortic valve repair is compared
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Erik Fosse, Oslo University Hospital
- Investigators
- Erik Fosse, MD PhD, Principal investigator, Oslo University Hospital/University of OsloKaroline KH Fiane, Med Student, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074838
- Sponsor's protocol ID
- 2012/7919
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fiane KKH, Dahle G, Bendz B, Halvorsen PS, Abdelnoor M, Mollnes TE, Fosse E. Reduced inflammatory response by transcatheter, as compared to surgical aortic valve replacement. Scand Cardiovasc J. 2018 Feb;52(1):43-50. doi: 10.1080/14017431.2017.1416157. Epub 2017 Dec 12.
PubMed 29233022
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Inflammatory Response Using Transcatheter Aortic Valve Replacement as Compared to Conventional Surgery
- ClinicalTrials.gov ID
- NCT03074838
- Acronym / sponsor ID
- 2012/7919
- Conditions
- Aortic Valve Stenosis
- Keywords
- Cardiac surgery, TAVI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 9 Mar 2017 (actual)
- 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.
A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.
Detailed description
18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (TAVI) (9 transfemoral and 9 transaortic) are included.
A plasma sample is obtained at defined timepoints before, during and after surgery. At each time points the following biomarkers are analyzed:Concentrations of the complement activation products C3bc and the terminal C5b-9 complement complex (TCC), the neutrophil release product myeloperoxidase (MPO), the cytokines IL-6, eotaxin, MCP-1 and MIP-1β (12). As marker of a myocardial cellular injury troponin T levels will be analyzed. The following clinical outcomes will also be monitored: Death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction.
A dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. The registry will be deleted after completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A case Control study were patients undergoing two surgical Methods for aortic valve repair is compared
| Arm | Type | Receives |
|---|---|---|
| Transarterial aortic valve implantation | Experimental | Procedure: Transarterial aortic valve implantation - TAVIPatients that are treated by trans arterial valve implantation (TAVI) |
| Surgical aortic valve replacement | Active comparator | Procedure: Surgical aortic valve replacement - SAVRPatients that are treated by surgical aortic valve replacement (SAVR) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for aortic valve replacement without need for concurrent surgery
Key exclusion criteria (1 listed)
- known inflammatory disease and anti-inflammatory treatment
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 |
|---|---|---|
| Transarterial aortic valve implantation - TAVIAfter insertion of a guidewire, either through the femoral artery or through the ascending aorta, the aortic ostium is dilated by a balloon and the valve is introduced through a catheter and expanded in the ostium. | Procedure or surgery | Transarterial aortic valve implantation |
| Surgical aortic valve replacement - SAVRThe patient is operated through a sternotomy and coupled to a heart lung machine. The aorta is opened and the native valve excised. Then a biological artificial heart valve is sutured in place. | Procedure or surgery | Surgical aortic valve replacement |
Primary outcome
Generation of several inflammatory markers measured through repeated blood samples
Time frame: 24 hours
The total generation of several inflammatory markers is compared between the groups
2 secondary outcomes
Blood loss
Time frame: 24 hrs
Blood transfusion
Time frame: 24 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 29233022Fiane KKH, Dahle G, Bendz B, Halvorsen PS, Abdelnoor M, Mollnes TE, Fosse E. Reduced inflammatory response by transcatheter, as compared to surgical aortic valve replacement. Scand Cardiovasc J. 2018 Feb;52(1):43-50. doi: 10.1080/14017431.2017.1416157. Epub 2017 Dec 12.
- Individual participant dataSharing planned: No
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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.
Erik Fosse, MD PhD principal investigator
Oslo University Hospital/University of Oslo
Karoline KH Fiane, Med Student study chair
University of Oslo
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial aortic valve implantation - TAVI and Surgical aortic valve replacement - SAVR in people with Aortic Valve Stenosis, run by Oslo University Hospital.
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 1 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: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Generation of several inflammatory markers measured through repeated blood samples (time frame: 24 hours). 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 NCT03074838, which also lists 1 linked publication.
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 9 Mar 2017.