Heart Valve DiseasesTP-TAVRNCT03826264
Transpacific TAVR Registry
An observational study of Heart Valve Diseases and Aortic Valve Insufficiency, run by Duk-Woo Park, MD at 7 sites in 3 countries.
Trial summary
This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Valve Diseases, Aortic Valve Insufficiency
- What is being tested?
- TAVR
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 15 Jun 2019to 31 Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- Adult, Older adult
Study population: All patients undergoing TAVR
Who may be able to join
- All patients undergoing TAVR
- Informed consent
Who cannot join
None listed.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Do-yoon Kang, MD contact
7 sites in 3 countries
South Korea4 sites, 2 recruiting
- Active, not recruiting
Bucheon Sejong Hospital
Bucheon-si
- Recruiting
Chungnam National University Hospital
Daejeon
Jae-hyung Park, MD
Jae-hyung Park, MD
- Recruiting
Asan Medical Center
Seoul
Duk-woo Park, MD, dwpark@amc.seoul.kr
Duk-woo Park, MD
- Completed
Seoul National University Hospital
Seoul
United States2 sites, 2 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
James D. Flaherty, MD
James D. Flaherty, MD
- Recruiting
Stanford University
Stanford, California, 94305
Alan Ching Yuen Yeung, MD
Alan Ching Yuenn Yeung, MD
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University
Hangzhou
Jian-an Wang, MD
Jian-an Wang, MD
About this study
Official title: a Multinational Multicenter Prospective Transpacific TAVR Registry
This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.
Read the detailed description
This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR registry continue 10 years follow-up on this TP-TAVR registry.
- Conditions
- Heart Valve Diseases, Aortic Valve Insufficiency
- Being tested
- TAVR
- Keywords
- TAVR, TAVI, real-world
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVRProcedure or surgery
transcatheter aortic valve replacement (TAVR)
| Study group | Role | What they receive |
|---|---|---|
| Korea Centers | Seoul, Korea All Patients undergoing TAVR Receives: Procedure: TAVR | |
| Stanford University | California, USA All Patients undergoing TAVR Receives: Procedure: TAVR | |
| Northwestern University | Evanston, Illinois, USA All Patients undergoing TAVR Receives: Procedure: TAVR | |
| Cheng-Hsin Hospital | Taipei, Taiwan All Patients undergoing TAVR Receives: Procedure: TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event rate of all cause death
Measured: 1 year
Secondary outcomes (15)
Event rate of cardiovascular death
- Death due to proximate cardiac cause B. Death caused by non-coronary vascular condition C. All procedure-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause
Measured: 10 years
Event rate of myocardial infarction
according to Valve Academic Research Consortium (VARC) criteria
Measured: 10 years
Event rate of cerebrovascular accident
stroke and TIA (Transient Ischemic Attack)
Measured: 10 years
Event rate of bleeding
according to Valve Academic Research Consortium (VARC) criteria
Measured: 10 years
Event rate of Vascular access site and access-related complication
according to Valve Academic Research Consortium (VARC) criteria
Measured: 30 days
Event rate of Acute kidney injury
Measured: 30 days
Event rate of Permanent pacemaker insertion
Measured: 10 years
Event rate of Other TAVR-related complication
- Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve mal-positioning H. TAV-in-TAV deployment
Measured: 10 years
Event rate of Prosthetic valve dysfunction
according to Valve Academic Research Consortium (VARC) criteria
- Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation
Measured: 10 years
Event rate of Composite endpoint
- Device success
- Early safety
: death, cerebrovascular event, fatal bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve dysfunction requiring intervention
- Clinical efficacy : death, cerebrovascular event, valve-related symptom requiring hospitalization or devastating heart failure, NYHA class* III, IV dyspnea, valve dysfunction
*the New York Heart Association (NYHA) Functional Classification
Measured: 10 years
Event rate of Structural valve deterioration
Measured: 10 years
NYHA class
Measured: 30 days
NYHA class
Measured: 1 year
Valve area
Measured: 1 year
Event rate of free from atrial fibrillation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start15 Jun 2019
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duk-Woo Park, MD
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Duk-Woo Park, MD, Asan Medical Center
- Investigators
- Alan Ching Yuen Yeung, MD, Principal investigator, Stanford UniversityJames D. Flaherty, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826264
- Sponsor's protocol ID
- AMCCV2019-01
- Acronym
- TP-TAVR
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2019
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim M, Kang DY, Ahn JM, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim HJ, Lee J, Park J, Kim H, Cho S, Choi Y, Park SJ, Park DW. Sex-Specific Disparities in Clinical Outcomes After Transcatheter Aortic Valve Replacement Among Different Racial Populations. JACC Asia. 2024 Feb 13;4(4):292-302. doi: 10.1016/j.jacasi.2023.11.016. eCollection 2024 Apr.
PubMed 38660112Kim H, Kang DY, Ahn JM, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim N, Kim M, Lee J, Park J, Choi Y, Park SJ, Park DW. Race-Specific Impact of Conventional Surgical Risk Score on 1-Year Mortality After Transcatheter Aortic Valve Replacement. JACC Asia. 2023 Feb 28;3(3):376-387. doi: 10.1016/j.jacasi.2022.11.007. eCollection 2023 Jun.
PubMed 37323869Kang DY, Ahn JM, Kim JB, Yeung A, Nishi T, Fearon W, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Park SY, Yun SC, Ko E, Park H, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park DW, Park SJ. Inter-racial differences in patients undergoing transcatheter aortic valve implantation. Heart. 2022 Sep 12;108(19):1562-1570. doi: 10.1136/heartjnl-2021-320364.
PubMed 35110384Park H, Ahn JM, Kang DY, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim S, Yun SC, Ko E, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park DW, Park SJ. Racial Differences in the Incidence and Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2670-2681. doi: 10.1016/j.jcin.2021.08.038. Epub 2021 Nov 24.
PubMed 34838464
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Multinational Multicenter Prospective Transpacific TAVR Registry
- ClinicalTrials.gov ID
- NCT03826264
- Acronym / sponsor ID
- TP-TAVR / AMCCV2019-01
- Conditions
- Heart Valve Diseases, Aortic Valve Insufficiency
- Keywords
- TAVR, TAVI, real-world
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Duk-Woo Park, MDUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 1 Feb 2019 (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 registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.
Detailed description
This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR registry continue 10 years follow-up on this TP-TAVR registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Korea Centers | – | Procedure: TAVRSeoul, Korea All Patients undergoing TAVR |
| Stanford University | – | Procedure: TAVRCalifornia, USA All Patients undergoing TAVR |
| Northwestern University | – | Procedure: TAVREvanston, Illinois, USA All Patients undergoing TAVR |
| Cheng-Hsin Hospital | – | Procedure: TAVRTaipei, Taiwan All Patients undergoing TAVR |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing TAVR
Key inclusion criteria (2 listed)
- All patients undergoing TAVR
- Informed consent
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 |
|---|---|---|
| TAVRtranscatheter aortic valve replacement (TAVR) | Procedure or surgery | Cheng-Hsin Hospital, Korea Centers, Northwestern University, Stanford University |
Primary outcome
Event rate of all cause death
Time frame: 1 year
15 secondary outcomes
Event rate of cardiovascular death
Time frame: 10 years
Event rate of myocardial infarction
Time frame: 10 years
Event rate of cerebrovascular accident
Time frame: 10 years
Event rate of bleeding
Time frame: 10 years
Event rate of Vascular access site and access-related complication
Time frame: 30 days
Event rate of Acute kidney injury
Time frame: 30 days
Event rate of Permanent pacemaker insertion
Time frame: 10 years
Event rate of Other TAVR-related complication
Time frame: 10 years
Event rate of Prosthetic valve dysfunction
Time frame: 10 years
Event rate of Composite endpoint
Time frame: 10 years
Event rate of Structural valve deterioration
Time frame: 10 years
NYHA class
Time frame: 30 days
NYHA class
Time frame: 1 year
Valve area
Time frame: 1 year
Event rate of free from atrial fibrillation
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Derived from this study: PubMed 38660112Kim M, Kang DY, Ahn JM, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim HJ, Lee J, Park J, Kim H, Cho S, Choi Y, Park SJ, Park DW. Sex-Specific Disparities in Clinical Outcomes After Transcatheter Aortic Valve Replacement Among Different Racial Populations. JACC Asia. 2024 Feb 13;4(4):292-302. doi: 10.1016/j.jacasi.2023.11.016. eCollection 2024 Apr.
- Derived from this study: PubMed 37323869Kim H, Kang DY, Ahn JM, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim N, Kim M, Lee J, Park J, Choi Y, Park SJ, Park DW. Race-Specific Impact of Conventional Surgical Risk Score on 1-Year Mortality After Transcatheter Aortic Valve Replacement. JACC Asia. 2023 Feb 28;3(3):376-387. doi: 10.1016/j.jacasi.2022.11.007. eCollection 2023 Jun.
- Derived from this study: PubMed 35110384Kang DY, Ahn JM, Kim JB, Yeung A, Nishi T, Fearon W, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Park SY, Yun SC, Ko E, Park H, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park DW, Park SJ. Inter-racial differences in patients undergoing transcatheter aortic valve implantation. Heart. 2022 Sep 12;108(19):1562-1570. doi: 10.1136/heartjnl-2021-320364.
- Derived from this study: PubMed 34838464Park H, Ahn JM, Kang DY, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim S, Yun SC, Ko E, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park DW, Park SJ. Racial Differences in the Incidence and Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2670-2681. doi: 10.1016/j.jcin.2021.08.038. Epub 2021 Nov 24.
- Individual participant dataSharing planned: Undecided
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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.
Do-yoon Kang, MD contact
Alan Ching Yuen Yeung, MD principal investigator
Stanford University
James D. Flaherty, MD principal investigator
Northwestern University
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases and Aortic Valve Insufficiency, run by Duk-Woo Park, MD at 7 sites in 3 countries.
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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea, United States, China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duk-woo Park, MD (82230103995, dwpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event rate of all cause death (time frame: 1 year). 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 NCT03826264, which also lists 4 linked publications.
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 2 Jan 2026.