TP-TAVR: Transpacific TAVR Registry

• Sponsor: Duk-Woo Park, MD (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03826264
• Collaborator: CardioVascular Research Foundation, Korea (Other)
• Enrollment: 4,000
• Locations: 7
• Anticipated Duration (Months): 150.5
• Patients Per Site: 571.4
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Diseases; Aortic Valve Insufficiency	Procedure: TAVR

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

• Study Type: Observational
• Anticipated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: a Multinational Multicenter Prospective Transpacific TAVR Registry
• Actual Study Start Date: Jun 15, 2019
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2031

Arms and Interventions

Arm	Intervention/Treatment
Korea Centers Seoul, Korea All Patients undergoing TAVR	Procedure: TAVR; transcatheter aortic valve replacement (TAVR)
Stanford University California, USA All Patients undergoing TAVR	Procedure: TAVR; transcatheter aortic valve replacement (TAVR)
Northwestern University Evanston, Illinois, USA All Patients undergoing TAVR	Procedure: TAVR; transcatheter aortic valve replacement (TAVR)
Cheng-Hsin Hospital Taipei, Taiwan All Patients undergoing TAVR	Procedure: TAVR; transcatheter aortic valve replacement (TAVR)

Outcome Measures

Primary Outcome Measures

1. Event rate of all cause death [1 year]

Secondary Outcome Measures

1. Event rate of cardiovascular death [10 years]

   A. 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

2. Event rate of myocardial infarction [10 years]

   according to Valve Academic Research Consortium (VARC) criteria

3. Event rate of cerebrovascular accident [10 years]

   stroke and TIA (Transient Ischemic Attack)

4. Event rate of bleeding [10 years]

   according to Valve Academic Research Consortium (VARC) criteria

5. Event rate of Vascular access site and access-related complication [30 days]

   according to Valve Academic Research Consortium (VARC) criteria

6. Event rate of Acute kidney injury [30 days]

7. Event rate of Permanent pacemaker insertion [10 years]

8. Event rate of Other TAVR-related complication [10 years]

   A. 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

9. Event rate of Prosthetic valve dysfunction [10 years]

   according to Valve Academic Research Consortium (VARC) criteria A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation

10. Event rate of Composite endpoint [10 years]

    A. Device success B. Early safety : death, cerebrovascular event, fatal bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve dysfunction requiring intervention C. 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

11. Event rate of Structural valve deterioration [10 years]

12. NYHA class [30 days]

13. NYHA class [1 year]

14. Valve area [1 year]

15. Event rate of free from atrial fibrillation [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• All patients undergoing TAVR

• Informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305
2	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
3	Second Affiliated Hospital of Zhejiang University	Hangzhou		China
4	Bucheon Sejong Hospital	Bucheon		Korea, Republic of
5	Chungnam National University Hospital	Daejeon		Korea, Republic of
6	Asan Medical Center	Seoul		Korea, Republic of
7	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Duk-Woo Park, MD
• CardioVascular Research Foundation, Korea

Investigators

• Principal Investigator: Alan Ching Yuen Yeung, MD, Stanford University
• Principal Investigator: James D. Flaherty, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duk-Woo Park, MD, Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03826264
• Other Study ID Numbers: AMCCV2019-01
• First Posted: Feb 1, 2019
• Last Update Posted: Feb 25, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duk-Woo Park, MD, Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Asan Medical Center: TAVR; TAVI; real-world
• Additional relevant MeSH terms: Heart Valve Diseases; Aortic Valve Insufficiency

Study Results

No Results Posted as of Feb 25, 2022