The Regional Collaborative Unite of Transcatheter Aortic Valve Implantation Registry in Thailand

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20250616016

Enrollment

300

Registered

2025-06-16

Start date

2025-06-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients who undergo transcatheter aortic valve implantation procedure at the study sites transcatheter aortic valve implantation structural valve deterioration bioprosthetic valve failure VARC-3

Interventions

transcatheter aortic valve implantation

Prevention

Group 1

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients who undergo TAVI procedure at the study sites.

Exclusion criteria

Exclusion criteria: 1. Any medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams. 2. Currently participating in an investigational drug or another device trial (excluding registries)

Design outcomes

Primary

Measure	Time frame
Event of structural valve deterioration (SVD) 2 year Valve Academic Research Consortium 3 (VARC-3) Criteria,Event of bioprosthetic valve failure (BVF) 2 year Valve Academic Research Consortium 3 (VARC-3) Criteria	—

Secondary

Measure	Time frame
Echocardiographic assessment at discharge, 1 months, 12 months, 24 months and annually thereafter up to 5 years Ejection Fraction ,Event of structural valve deterioration 2 year SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial,Event of structural valve deterioration 2 year European Association for Cardio-Thoracic Surgery (EACTS) - European Association of Percutaneous Cardiovascular Interventions (EAPCI) definitions ,Event of All-cause mortality, heart failure hospitalization and major stroke 2 year Number of Event,Events of Major Adverse Cardiovascular and Cerebrovascular at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of Event,Event of individual Major Adverse Cardiac and Cerebrovascular Events (MACCE) components at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of Major Adverse Cardiac and Cerebrovascular Events (MACCE) component,Event of abnormal conduction requiring permanent pacemaker implantation at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of permanent pacemaker implantation,Event of Heart failure hospitalization at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of Heart failure hospitalization ,Quality of Life (QoL) at baseline, 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Quality of Life criteria,Cardiovascular deaths rates at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of rates,Strokes and Transient Ischemic Attack rates at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of rates,Device success rates at discharge Number of rates	—

Measure

Time frame

Echocardiographic assessment at discharge, 1 months, 12 months, 24 months and annually thereafter up to 5 years Ejection Fraction ,Event of structural valve deterioration 2 year SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial,Event of structural valve deterioration 2 year European Association for Cardio-Thoracic Surgery (EACTS) - European Association of Percutaneous Cardiovascular Interventions (EAPCI) definitions ,Event of All-cause mortality, heart failure hospitalization and major stroke 2 year Number of Event,Events of Major Adverse Cardiovascular and Cerebrovascular at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of Event,Event of individual Major Adverse Cardiac and Cerebrovascular Events (MACCE) components at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of Major Adverse Cardiac and Cerebrovascular Events (MACCE) component,Event of abnormal conduction requiring permanent pacemaker implantation at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of permanent pacemaker implantation,Event of Heart failure hospitalization at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of Heart failure hospitalization ,Quality of Life (QoL) at baseline, 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Quality of Life criteria,Cardiovascular deaths rates at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of rates,Strokes and Transient Ischemic Attack rates at 1 months, 6 months, 12 months, 24 months, and annually thereafter up to 5 years Number of rates,Device success rates at discharge Number of rates

—

Countries

Thailand

Contacts

Public ContactTasalak Thonghong

Faculty of Medicine, Chiang Mai University

tasalak.t@cmu.ac.th6653936793

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026