Aortic Valve StenosisNCT03051334
Ascending Aortic Dilation in BiAV After TAVR
An observational study of Aortic Valve Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- diagnosed as bicuspid aortic valve
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2007to 30 Dec 2017
- 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 21 years and older
- All sexes
- Adult, Older adult
Study population: Severe AS who underwent TAVR
Who may be able to join
- Severe AS who underwent TAVR
Who cannot join
- ascending aorta more than 50mm
Trial locations and contacts
1 site in 1 country.
Hyung-Kwan Kim, MD, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hyung-Kwan Kim, MD, 82-2-2072-0243
Hyung-Kwan Kim, MD
About this study
Official title: Changes in Ascending Aorta Size After Transcatheter Aortic Valve Replacement in Severe Bicuspid Aortic Stenosis: A Pilot Study With Echocardiographic Follow-up
This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).
Read the detailed description
The growth rate of ascending aorta was calculated as annual growth rate using baseline and the last echocardiography. The difference in ascending aorta growth rates between the two groups (BiAV and TAV) were analyzed by independent t-test.
- Conditions
- Aortic Valve Stenosis
- Being tested
- diagnosed as bicuspid aortic valve
- 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.
diagnosed as bicuspid aortic valveOther
| Study group | Role | What they receive |
|---|---|---|
| BiAV | Bicuspid aortic valve Receives: Other: diagnosed as bicuspid aortic valve | |
| TAV | Tricuspid aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in dimension of ascending aorta
the annual growth rate of ascending aorta(mm/year) using echocardiography
Measured: baseline and 1year after TAVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Jan 2007
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Dec 2017 (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 Seoul National 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung-Kwan Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051334
- Sponsor's protocol ID
- 1701-104-825
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ascending Aorta Size After Transcatheter Aortic Valve Replacement in Severe Bicuspid Aortic Stenosis: A Pilot Study With Echocardiographic Follow-up
- ClinicalTrials.gov ID
- NCT03051334
- Acronym / sponsor ID
- 1701-104-825
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 13 Feb 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.
This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).
Detailed description
The growth rate of ascending aorta was calculated as annual growth rate using baseline and the last echocardiography. The difference in ascending aorta growth rates between the two groups (BiAV and TAV) were analyzed by independent t-test.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiAV | – | Other: diagnosed as bicuspid aortic valveBicuspid aortic valve |
| TAV | – | –Tricuspid aortic valve |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Severe AS who underwent TAVR
Key inclusion criteria (1 listed)
- Severe AS who underwent TAVR
Key exclusion criteria (1 listed)
- ascending aorta more than 50mm
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 |
|---|---|---|
| diagnosed as bicuspid aortic valve | Other | BiAV |
Primary outcome
changes in dimension of ascending aorta
Time frame: baseline and 1year after TAVR
the annual growth rate of ascending aorta(mm/year) using echocardiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Hyung-Kwan Kim, MD, PhD contact
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 Seoul National University Hospital at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 13 Feb 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 South Korea. 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 Ji-Hyun Jung, MD (82-2-2072-0243, jbjhyun@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in dimension of ascending aorta (time frame: baseline and 1year after TAVR). 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 13 Feb 2017.