Aortic StenosisNCT02005640
Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study
An observational study of Aortic Stenosis, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Sep 2012
- Phase
- Observational
- 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
Study population: Primary analysis will be done in patients with a successful THV implantation and availability of high quality echocardiographic assessment and in the post routing MSCT group on the availability of a high quality MSCT scan.
Who may be able to join
- Patients implanted with a THV at Aarhus University Hospital
Who cannot join
- Learning curve patients (the first 40 patients implanted with a THV device at Aarhus University Hospital, Skejby).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology and Cardiothoracic Surgery, Aarhus University Hospital
Aarhus N, 8000
About this study
The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.
- Conditions
- Aortic Stenosis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MSCT-based prothesis sizing | Not described | |
| Echocardiographic-based prothesis sizing | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT
Measured: 1 week to 3 months post-TAVI
MSCT vs. echocardiographic aortic valve sizing before TAVI
Measured: time of TAVI
THV size before and after introduction of routing preoperative MSCT
Measured: time of TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Romer Krusell, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005640
- Sponsor's protocol ID
- MSCT-TAVI 1
- Status last verified
- Mar 2015
- First submitted
- 3 Dec 2013
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study
- ClinicalTrials.gov ID
- NCT02005640
- Acronym / sponsor ID
- MSCT-TAVI 1
- Conditions
- Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Dec 2013 (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 objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSCT-based prothesis sizing | – | – |
| Echocardiographic-based prothesis sizing | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary analysis will be done in patients with a successful THV implantation and availability of high quality echocardiographic assessment and in the post routing MSCT group on the availability of a high quality MSCT scan.
Key inclusion criteria (1 listed)
- Patients implanted with a THV at Aarhus University Hospital
Key exclusion criteria (1 listed)
- Learning curve patients (the first 40 patients implanted with a THV device at Aarhus University Hospital, Skejby).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT
Time frame: 1 week to 3 months post-TAVI
MSCT vs. echocardiographic aortic valve sizing before TAVI
Time frame: time of TAVI
THV size before and after introduction of routing preoperative MSCT
Time frame: time of TAVI
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 19 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stenosis, run by Aarhus University Hospital Skejby 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 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 19 Mar 2015. 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?
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?
Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT (time frame: 1 week to 3 months post-TAVI). The study lists 3 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 19 Mar 2015.