Aortic Valve StenosisNCT02288871
Pilot Trial: Comparison of Flow Patterns
A study testing Cardiac CT-scan in people with Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- What is being tested?
- Cardiac CT-scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2014to Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient underwent open aortic valve replacement with either an Edwards Magna Ease or an Edwards Intuity valve
- Implanted valve size 23mm
- Surgical access via full sternotomy or hemisternotomy
- Intuity Valve System implanted by one of the clinical investigators of the TRITON trial (http://clinicaltrials.gov/show/NCT01445171) at the Medical University of Vienna
- Post-operative ejection fraction ≥50%
- Sinus-Rhythm
- Ability to understand and comply with study procedures
- Signed informed consent
Who cannot join
- Under 18 years of age
- Emergency surgery
- Pregnancy
- Previous aortic root replacement
- Previous aortic valve replacement
- Previous or concomitant root enlargement
Show all 16Show fewer
- Previous or concomitant repair of the ascending aorta
- Paravalvular leakage
- Ectasia of the ascending aorta
- Previous or concomitant myomectomy
- Concomitant replacement or repair of valves other than aortic
- Usage of more than 3 sutures for implantation of the Intuity Valve System
- Heavily calcified aortic root
- Glomerular filtration rate (GFR) < 30 ml/min
- Inability to understand or comply with study procedures
- Known allergic reaction to iodinated, non-ionic contrast agents
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Claus Rath, MD, 0043-1-40400-69660, claus.rath@meduniwien.ac.at
Alfred Kocher, MD, 0043-1-40400-69660, alfred.kocher@meduniwien.ac.at
About this study
Official title: Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?
The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.
Our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Being tested
- Cardiac CT-scan
- Keywords
- aortic valve replacement, aortic valve bioprosthesis, hemodynamics
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT-scanRadiation
ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs).
In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves.
| Study group | Role | What they receive |
|---|---|---|
| "Sutureless" valve | Other | Patients who underwent aortic valve replacement with a "sutureless" aortic valve.
An echocardiogram and a cardiac CT-scan will be conducted. Receives: Radiation: Cardiac CT-scan |
| "Sewed-in" valve | Other | Patients who underwent aortic valve replacement with a "sewed-in" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted. Receives: Radiation: Cardiac CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of maximum and minimum velocity under patient specific conditions
Measured: between 6 months and 4 years after aortic valve replacement
Comparison of the effective orifice area under patient specific conditions
Measured: between 6 months and 4 years after aortic valve replacement
Comparison of the percentage of turbulent flow under patient specific conditions
Measured: between 6 months and 4 years after aortic valve replacement
Comparison of the pressure drop under patient specific conditions
Measured: between 6 months and 4 years after aortic valve replacement
Secondary outcomes (2)
Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
The first secondary outcome measure is the comparison of
-pressure gradients
as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified.
If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics."
Measured: between 6 months and 4 years after aortic valve replacement
Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.
The second secondary outcome measure is the comparison of
-peak velocity
as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified.
If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics."
Measured: between 6 months and 4 years after aortic valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Alfred A Kocher, MD, Medical University of Vienna
- Investigators
- Alfred Kocher, MD, Principal investigator, Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288871
- Sponsor's protocol ID
- 1790/2013-1
- Status last verified
- Mar 2018
- First submitted
- 22 Oct 2014
- Last updated
- 27 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?
- ClinicalTrials.gov ID
- NCT02288871
- Acronym / sponsor ID
- 1790/2013-1
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Keywords
- aortic valve replacement, aortic valve bioprosthesis, hemodynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Oct 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Nov 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.
The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.
Our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Sutureless" valve | Other | Radiation: Cardiac CT-scanPatients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted. |
| "Sewed-in" valve | Other | Radiation: Cardiac CT-scanPatients who underwent aortic valve replacement with a "sewed-in" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient underwent open aortic valve replacement with either an Edwards Magna Ease or an Edwards Intuity valve
- Implanted valve size 23mm
- Surgical access via full sternotomy or hemisternotomy
- Intuity Valve System implanted by one of the clinical investigators of the TRITON trial (http://clinicaltrials.gov/show/NCT01445171) at the Medical University of Vienna
- Post-operative ejection fraction ≥50%
Key exclusion criteria (16 listed)
- Under 18 years of age
- Emergency surgery
- Pregnancy
- Previous aortic root replacement
- Previous aortic valve replacement
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 |
|---|---|---|
| Cardiac CT-scanECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs). In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves. | Radiation | "Sewed-in" valve, "Sutureless" valve |
Primary outcome
Comparison of maximum and minimum velocity under patient specific conditions
Time frame: between 6 months and 4 years after aortic valve replacement
Comparison of the effective orifice area under patient specific conditions
Time frame: between 6 months and 4 years after aortic valve replacement
Comparison of the percentage of turbulent flow under patient specific conditions
Time frame: between 6 months and 4 years after aortic valve replacement
Comparison of the pressure drop under patient specific conditions
Time frame: between 6 months and 4 years after aortic valve replacement
2 secondary outcomes
Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
Time frame: between 6 months and 4 years after aortic valve replacement
Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.
Time frame: between 6 months and 4 years after aortic valve replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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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.
Alfred Kocher, MD principal investigator
Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CT-scan in people with Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Medical University of Vienna at 1 site in Austria.
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 8 inclusion and 16 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 27 Mar 2018. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claus Rath, MD (0043-1-40400-69660, claus.rath@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of maximum and minimum velocity under patient specific conditions (time frame: between 6 months and 4 years after aortic valve replacement). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2018.