NCT06874465

Transcatheter Aortic Valve Implantation Registry at the National Research Center for Cardiac Surgery, Nur-Sultan, Kazakhstan

TAVI Registry at the National Research Center for Cardiac Surgery, Astana, Kazakhstan

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Research Center for Cardiac Surgery, Kazakhstan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will analyze patients with aortic stenosis who have undergone transcatheter valve implantation and surgical aortic valve replacement. Afterwards, the results of these two procedures will be collected to the database and compared among the Kazakhstani population.

Detailed description

Primary Objectives 1. Prevalence of aortic stenosis in Kazakhstan regions 2. 12 months survival of patients after TAVI 3. Intra- and postoperative complications 4. Conduction disorders after TAVI 5. Left ventricle function after TAVI in patients with low ejection fraction 6. Comparison of aortic route dimensions by 3D-TEE and MSCT 7. Comparison of TAVR with SAVR Study Design Registry, IV phase Subject Follow-up Schedule Maximum follow-up is approximately 4 years. Inclusion Criteria Patients have TAVI Exclusion Criteria Patients have not TAVI Primary Endpoints The database contains data on mortality, intraoperative complications, post-operative complications and adverse cardiovascular events. We will perform Quality of Life analysis before TAVI and one year later, using the Short-Form 36 (SF36) instrument on 70% of our patients. Patient Safety The NRCCS is a leading center for interventional cardiology in Kazakhstan, and in Central Asia, performing a high volume of TAVI procedures annually Procedure / Intervention Description * We believe our database is unique because it is the first systematically-collected, prospectively designed database in Central Asia for patients receiving TAVI. * As known there is no data has been published regarding TAVI in Central Asia. Secondary Endpoints * Surgeons at NRCCS tend to use biological valves over mechanical valves because it was recognized that the requirements for long term success of mechanical valves (e.g. warfarin maintenance and compliance) were unlikely to be achieved in our patient population, many of whom live in rural areas without access to advanced cardiology care. * Some of these patients are now returning to our center for valve in valve implantation and are being included in our registry. • Foundational work has been completed through our database development, but there is significant potential to expand our data collection to other Central Asian interventional cardiology centers. * As technology evolves and options for trans-femoral TAVI approaches increase, the likelihood of using TAVI over SAVR will increase in Kazakhstan and Central Asia. Statistical Method / Rationale Foundational work has been completed through our database development, but there is significant potential to expand our data collection to other Central Asian interventional cardiology centers. As technology evolves and options for trans-femoral TAVI approaches increase, the likelihood of using TAVI over SAVR will increase in Kazakhstan and Central Asia.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter aortic valve implantation	Compare self expendable and balloon expendable valves

Timeline

• Start date: 2020-01-10
• Primary completion: 2021-01-10
• Completion: 2026-01-10
• First posted: 2025-03-13
• Last updated: 2025-03-13

Locations

1 site across 1 country: Kazakhstan