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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06874465
Enrollment
100
Registered
2025-03-13
Start date
2020-01-10
Completion date
2026-01-10
Last updated
2025-03-13

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

Conditions

Aortic Valve Stenosis

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.

Interventions

DEVICETranscatheter aortic valve implantation

Compare self expendable and balloon expendable valves

Sponsors

Medtronic Cardiovascular
CollaboratorINDUSTRY
National Research Center for Cardiac Surgery, Kazakhstan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of death1 year12 month all-cause of mortality
Evaluate of echocardiographic results1 yearechocardiographic parameters: Aortic valve orifice area, aortic valve bioprosthetic gradient (peak, mean), aortic valve bioprosthetic velocity, ejection fracrion of left ventricle (LVEF%).
Incidence of strokewithin 30 days and 12 monthsprocedure associated stroke and 12 months
Permanent pacemaker implantationwithin 30 daysprocedure associated AB block which is need for permanent pacemaker implantation

Secondary

MeasureTime frameDescription
Life qualityBaseline, 12 monthsQuality of life on 36-item short-form (SF 36) will be carry before and 12 months after the procedure

Countries

Kazakhstan

Contacts

Primary ContactAbdurashid Mussayev, PhD
abdurashid.mussayev@gmail.com+77029997667
Backup ContactSadyk Khamitov
sadyk.kh@gmail.com+77055756439

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026