ClinicalTrials.gg
Sign In
RecruitingNCT06874465Updated Mar 13, 2025

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

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

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2020, registered Oct 2020).
  • Started Jan 2020; still recruiting 6 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aortic Valve Stenosis
03

In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 100 is below the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

National Research Center for Cardiac Surgery, Kazakhstan is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 II or greater

Exclusion criteria

Exclusion Criteria:

  • Patients has active endocarditis
  • Patients has history of cerebral vascular accident or within the past 3 months
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceTranscatheter aortic valve implantation

    Compare self expendable and balloon expendable valves

    Also known as: Surgical aortic valve replacement

06

What researchers measure

Primary outcomes

  1. Number of death

    12 month all-cause of mortality

    Time frame: 1 year

  2. 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

  3. Incidence of stroke

    procedure associated stroke and 12 months

    Time frame: within 30 days and 12 months

  4. Permanent pacemaker implantation

    procedure associated AB block which is need for permanent pacemaker implantation

    Time frame: within 30 days

Secondary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • National Research Center for Cardiac Surgery
    Astana, 010000, Kazakhstan
    Recruiting
    • Abdurashid Mussayev, PhD · Contactabdurashid.mussayev@gmail.com · +77029997667
    • Serik Alimbayev, PhD · Principal investigator
    • Timur Lesbekov, PhD · Principal investigator
    • Aidyn Kuanyshbek, MD · Sub investigator
    • Marat Aripov, PhD · Sub investigator
    • Nursultan Tanaliyev, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Jan 2021, 12 months.

Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's 12 months is below that.

Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2020
First posted
Mar 13, 2025
StartActual
Jan 10, 2020
Primary completionActual
Jan 10, 2021
CompletionEst.
Jan 10, 2026
Last update
Mar 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06874465
Lead sponsor
National Research Center for Cardiac Surgery, Kazakhstan
Collaborators
Medtronic Cardiovascular
Responsible party
Abdurashid (Head of the department of the catheterization laboratory, National Research Center for Cardiac Surgery, Kazakhstan) — Principal investigator
First posted
Mar 13, 2025
Start date
Jan 10, 2020
Primary completion
Jan 10, 2021
Completion
Jan 10, 2026 (estimated)
Last update
Mar 13, 2025

Study contacts

Abdurashid Mussayev, PhD
Contact
abdurashid.mussayev@gmail.com
+77029997667
Sadyk Khamitov
Contact
sadyk.kh@gmail.com
+77055756439

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Other studies in this condition

Aortic Valve Stenosis →

Other studies from this sponsor

National Research Center for Cardiac Surgery, Kazakhstan

Start the discussion