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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

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

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Patients has active endocarditis
  • Patients has history of cerebral vascular accident or transient ischemic attack within the past 3 months
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • National Research Center for Cardiac Surgery
    Astana, 010000, Kazakhstan
    • Abdurashid Mussayev, PhD · Contact · abdurashid.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
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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
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