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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Transcatheter aortic valve implantation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdurashid Mussayev, PhD; Phone Number: +77029997667; Email: abdurashid.mussayev@gmail.com
• Study Contact Backup: Name: Sadyk Khamitov; Phone Number: +77055756439; Email: sadyk.kh@gmail.com

Study Locations

• Kazakhstan
  • Astana, Kazakhstan, 010000
    • Recruiting
    • National Research Center for Cardiac Surgery
    • Contact: Abdurashid Mussayev, PhD; Phone Number: +77029997667; Email: abdurashid.mussayev@gmail.com
    • Principal Investigator: Serik Alimbayev, PhD
    • Principal Investigator: Timur Lesbekov, PhD
    • Sub-Investigator: Aidyn Kuanyshbek, MD
    • Sub-Investigator: Marat Aripov, PhD
    • Sub-Investigator: Nursultan Tanaliyev, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients after transcatheter aortic valve replacement; Patients after transcatheter aortic valve replacement We will compare TAVI with SAVR 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.	Device: Transcatheter aortic valve implantation; Compare self expendable and balloon expendable valves; Other Names: Surgical aortic valve replacement
Active Comparator: Patients after surgical aortic valve replacement; Patients after surgical aortic valve replacement We will compare TAVI with SAVR 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.	Device: Transcatheter aortic valve implantation; Compare self expendable and balloon expendable valves; Other Names: Surgical aortic valve replacement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Research Center for Cardiac Surgery, Kazakhstan
• Collaborators: Medtronic Cardiovascular

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): January 10, 2021
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: v. 1; ERP-2019-11795 (Other Grant/Funding Number: Medtronic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No