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.
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
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.
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
- Investigators
- Seung-jung Park, MD, PhD, Principal investigator, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of MedicineGerald Yong, MD, Principal investigator, Perth Cardiovascular Institute, Royal Perth Hospital 197 Wellington Street, Perth WA 6000, AustraliaEdgar Tay, MD, Principal investigator, Department of Cardiology, National University Hospital Singapore, 5 Lower Kent Ridge Road, Singapore 119074, SingaporeFabian Nietlispach, MD, PhD, Principal investigator, Department of Cardiology, University Heart Center, Raemistrasse 100, CH-8091 Zurich, SwitzerlandCorrado Tamburino, MD, Principal investigator, Division of Cardiology, Ferrarotto Hospital, University of Catania; ETNA Foundation Via Citelli 6, 95124, Catania, ItalyThierry Lefèvre, MD, Principal investigator, Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, FranceMarie-Claude Morice, MD, Principal investigator, Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, FranceJeroen J. Bax, MD, PhD, Principal investigator, Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands
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