An interventional study of Transcatheter aortic valve implantation in Aortic Valve Stenosis, sponsored by National Research Center for Cardiac Surgery, Kazakhstan. Recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by National Research Center for Cardiac Surgery, Kazakhstan · Not applicable, Interventional, and Treatment
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.
Primary Objectives
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
Secondary Endpoints
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.
Exclusion Criteria:
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
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
Also known as: Surgical aortic valve replacement
Number of death
12 month all-cause of mortality
Time frame: 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%).
Time frame: 1 year
Incidence of stroke
procedure associated stroke and 12 months
Time frame: within 30 days and 12 months
Permanent pacemaker implantation
procedure associated AB block which is need for permanent pacemaker implantation
Time frame: within 30 days
Life quality
Quality of life on 36-item short-form (SF 36) will be carry before and 12 months after the procedure
Time frame: Baseline, 12 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Research Center for Cardiac Surgery, Kazakhstan