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

Not Applicable

Recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT06874465
• Lead Sponsor: National Research Center for Cardiac Surgery, Kazakhstan

Brief 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.

Study Timeline

• Study Start: 2020-01-10
• Study First Submitted: 2020-10-12
• Primary Completion: 2021-01-10
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients has given written informed Concent for study participation prior to procedure
• Patients with Aortic Valve stenosis
• Patients has severe degenerative or congenital aortic stenosis.
• Patients has symptomatic aortic stenosis as demonstrated by NYHA II or greater

Exclusion Criteria

• Patients has active endocarditis
• Patients has history of cerebral vascular accident or transient ischemic attack within the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of death	1 year	12 month all-cause of mortality
Incidence of stroke	within 30 days and 12 months	procedure associated stroke and 12 months
Permanent pacemaker implantation	within 30 days	procedure associated AB block which is need for permanent pacemaker implantation
Evaluate of echocardiographic results	1 year	echocardiographic parameters: Aortic valve orifice area, aortic valve bioprosthetic gradient (peak, mean), aortic valve bioprosthetic velocity, ejection fracrion of left ventricle (LVEF%).

Secondary Outcome Measures

Name	Time	Method
Life quality	Baseline, 12 months	Quality of life on 36-item short-form (SF 36) will be carry before and 12 months after the procedure

Trial Locations

Locations (1)

National Research Center for Cardiac Surgery; 🇰🇿 Astana, Kazakhstan