Aortic Valve StenosisBicuspid TAVRNCT02394184

The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

An observational study of Aortic Valve Stenosis and Cardiovascular Diseases, run by Seung-Jung Park at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis. Read more about this study

Who is it for?: Any age
Conditions the study is for: Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases
What is being tested?: transcatheter aortic valve replacement
Type of treatment: Surgery or procedure
How many people: 102 participants
Where: 1 siteSouth Korea
Study dates: May 2015to 24 Sep 2019
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: patients with bicuspid aortic valve stenosis

Who may be able to join

Patients with bicuspid aortic valve stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Asan Medical Center
Seoul

Other trials in South Korea

About this study

Official title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement for Patients With Bicuspid Aortic Valve Stenosis

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.

Read the detailed description

This registry is a subgroup of Asian TAVR registry(NCT02308150) and Asian TAVR registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.

Conditions: Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Bicuspid
Being tested: transcatheter aortic valve replacement
Keywords: transcatheter aortic valve replacement
Medical subject headings: Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Bicuspid Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcatheter aortic valve replacementProcedure or surgery

Study groups in NCT02394184
Study group	Role	What they receive
patients with bicuspid aortic valve stenosis		Not described Receives: Procedure: transcatheter aortic valve replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

Death
Measured: 1 month
Death
Measured: 6 months
Death
Measured: 1 year
Death
Measured: 2 years
Death
Measured: 3 years
Death
Measured: 4 years
Death
Measured: 5 years

Secondary outcomes (59)

Death from cardiac cause
Measured: 1 month
Death from cardiac cause
Measured: 6 months
Death from cardiac cause
Measured: 1 year
Death from cardiac cause
Measured: 2 years
Death from cardiac cause
Measured: 3 years
Death from cardiac cause
Measured: 4 years
Death from cardiac cause
Measured: 5 years
Stroke
Measured: 1 month
Stroke
Measured: 6 months
Stroke
Measured: 1 year
Stroke
Measured: 2 years
Stroke
Measured: 3 years
Stroke
Measured: 4 years
Stroke
Measured: 5 years
Myocardial infarction
Measured: 1 month
Myocardial infarction
Measured: 6 months
Myocardial infarction
Measured: 1 year
Myocardial infarction
Measured: 2 years
Myocardial infarction
Measured: 3 years
Myocardial infarction
Measured: 4 years
Myocardial infarction
Measured: 5 years
Repeat hospitalization
Measured: 1 month
Repeat hospitalization
Measured: 6 months
Repeat hospitalization
Measured: 1 year
Repeat hospitalization
Measured: 2 years
Repeat hospitalization
Measured: 3 years
Repeat hospitalization
Measured: 4 years
Repeat hospitalization
Measured: 5 years
Acute kidney injury
Measured: 1 month
Acute kidney injury
Measured: 6 months
Acute kidney injury
Measured: 1 year
Acute kidney injury
Measured: 2 years
Acute kidney injury
Measured: 3 years
Acute kidney injury
Measured: 4 years
Acute kidney injury
Measured: 5 years
Vascular complication
Measured: 1 month
Vascular complication
Measured: 6 months
Vascular complication
Measured: 1 year
Vascular complication
Measured: 2 years
Vascular complication
Measured: 3 years
Vascular complication
Measured: 4 years
Vascular complication
Measured: 5 years
Bleeding events
Measured: 1 month
Bleeding events
Measured: 6 months
Bleeding events
Measured: 1 year
Bleeding events
Measured: 2 years
Bleeding events
Measured: 3 years
Bleeding events
Measured: 4 years
Bleeding events
Measured: 5 years
Device success
Measured: 1 month
Device success
Measured: 6 months
Device success
Measured: 1 year
Device success
Measured: 2 years
Device success
Measured: 3 years
Device success
Measured: 4 years
Device success
Measured: 5 years
Early safety as a composite of all cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, valve related dysfunction requiring repeat procedure
Measured: 1 month
Clinical Efficacy as a composite of all cause mortality, all stroke, hospitalization for valve related symptoms or worsening congestive heart failure, NYHA class III or IV, prosthetic heart valve dysfunction
Measured: 1 month, 6 months, and annually at 1 to 5 years
Time related valve safety as a composite of structural valve deterioration, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, VARC bleeding(unless clearly unrelated to valve therapy)
Measured: from index procedure to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201524 Sep 2019

First posted20 Mar 2015 (estimated)
Study startMay 2015
Primary completion24 Sep 2019
Study completion24 Sep 2019

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.
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: Prospective
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02394184
Sponsor's protocol ID: AMCCV2014-14_sub
Acronym: Bicuspid TAVR
Status last verified: Dec 2019
First submitted: 9 Mar 2015
Last updated: 26 Dec 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No: This is not a publicly funded trial.

Publications

Yoon SH, Lefevre T, Ahn JM, Perlman GY, Dvir D, Latib A, Barbanti M, Deuschl F, De Backer O, Blanke P, Modine T, Pache G, Neumann FJ, Ruile P, Arai T, Ohno Y, Kaneko H, Tay E, Schofer N, Holy EW, Luk NHV, Yong G, Lu Q, Kong WKF, Hon J, Kao HL, Lee M, Yin WH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Kim HS, Butter C, Khalique OK, Schaefer U, Nietlispach F, Kodali SK, Leon MB, Ye J, Chevalier B, Leipsic J, Delgado V, Bax JJ, Tamburino C, Colombo A, Sondergaard L, Webb JG, Park SJ. Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis. J Am Coll Cardiol. 2016 Sep 13;68(11):1195-1205. doi: 10.1016/j.jacc.2016.06.041.
PubMed 27609682

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement for Patients With Bicuspid Aortic Valve Stenosis
ClinicalTrials.gov ID: NCT02394184
Acronym / sponsor ID: Bicuspid TAVR / AMCCV2014-14_sub
Conditions: Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Bicuspid
Keywords: transcatheter aortic valve replacement
Study type: Observational
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Seung-Jung ParkUniversity, hospital or other
Collaborators: CardioVascular Research Foundation, Korea
Study start: May 2015
Primary completion: 24 Sep 2019 (actual)
Study completion: 24 Sep 2019 (actual)
First posted: 20 Mar 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.

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
patients with bicuspid aortic valve stenosis	–	Procedure: transcatheter aortic valve replacement

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: patients with bicuspid aortic valve stenosis

Key inclusion criteria (2 listed)

Patients with bicuspid aortic valve stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Key exclusion criteria (0 listed)

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
transcatheter aortic valve replacement	Procedure or surgery	patients with bicuspid aortic valve stenosis

Primary outcome

Death
Time frame: 1 month
Death
Time frame: 6 months
Death
Time frame: 1 year
Death
Time frame: 2 years
Death
Time frame: 3 years
Death
Time frame: 4 years
Death
Time frame: 5 years

59 secondary outcomes

Death from cardiac cause
Time frame: 1 month
Death from cardiac cause
Time frame: 6 months
Death from cardiac cause
Time frame: 1 year
Death from cardiac cause
Time frame: 2 years
Death from cardiac cause
Time frame: 3 years
Death from cardiac cause
Time frame: 4 years
Death from cardiac cause
Time frame: 5 years
Stroke
Time frame: 1 month
Stroke
Time frame: 6 months
Stroke
Time frame: 1 year
Stroke
Time frame: 2 years
Stroke
Time frame: 3 years
Stroke
Time frame: 4 years
Stroke
Time frame: 5 years
Myocardial infarction
Time frame: 1 month
Myocardial infarction
Time frame: 6 months
Myocardial infarction
Time frame: 1 year
Myocardial infarction
Time frame: 2 years
Myocardial infarction
Time frame: 3 years
Myocardial infarction
Time frame: 4 years
Myocardial infarction
Time frame: 5 years
Repeat hospitalization
Time frame: 1 month
Repeat hospitalization
Time frame: 6 months
Repeat hospitalization
Time frame: 1 year
Repeat hospitalization
Time frame: 2 years
Repeat hospitalization
Time frame: 3 years
Repeat hospitalization
Time frame: 4 years
Repeat hospitalization
Time frame: 5 years
Acute kidney injury
Time frame: 1 month
Acute kidney injury
Time frame: 6 months
Acute kidney injury
Time frame: 1 year
Acute kidney injury
Time frame: 2 years
Acute kidney injury
Time frame: 3 years
Acute kidney injury
Time frame: 4 years
Acute kidney injury
Time frame: 5 years
Vascular complication
Time frame: 1 month
Vascular complication
Time frame: 6 months
Vascular complication
Time frame: 1 year
Vascular complication
Time frame: 2 years
Vascular complication
Time frame: 3 years

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 26 Dec 2019.
Derived from this study: PubMed 27609682Yoon SH, Lefevre T, Ahn JM, Perlman GY, Dvir D, Latib A, Barbanti M, Deuschl F, De Backer O, Blanke P, Modine T, Pache G, Neumann FJ, Ruile P, Arai T, Ohno Y, Kaneko H, Tay E, Schofer N, Holy EW, Luk NHV, Yong G, Lu Q, Kong WKF, Hon J, Kao HL, Lee M, Yin WH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Kim HS, Butter C, Khalique OK, Schaefer U, Nietlispach F, Kodali SK, Leon MB, Ye J, Chevalier B, Leipsic J, Delgado V, Bax JJ, Tamburino C, Colombo A, Sondergaard L, Webb JG, Park SJ. Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis. J Am Coll Cardiol. 2016 Sep 13;68(11):1195-1205. doi: 10.1016/j.jacc.2016.06.041.
Individual participant dataSharing planned: No. This is not a publicly funded trial.

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.

Seung-jung Park, MD, PhD principal investigator

Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine

Gerald Yong, MD principal investigator

Perth Cardiovascular Institute, Royal Perth Hospital 197 Wellington Street, Perth WA 6000, Australia

Edgar Tay, MD principal investigator

Department of Cardiology, National University Hospital Singapore, 5 Lower Kent Ridge Road, Singapore 119074, Singapore

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 and Cardiovascular Diseases, run by Seung-Jung Park 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 2 inclusion and 0 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 26 Dec 2019. 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?

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?

Death (time frame: 1 month). The study lists 7 primary outcomes in all. 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 NCT02394184, 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 26 Dec 2019.