Aortic Valve StenosisNCT06874465
Transcatheter Aortic Valve Implantation Registry at the National Research Center for Cardiac Surgery, Nur-Sultan, Kazakhstan
A study testing Transcatheter aortic valve implantation in people with Aortic Valve Stenosis, run by National Research Center for Cardiac Surgery, Kazakhstan at 1 site in Kazakhstan.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transcatheter aortic valve implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKazakhstan
- Study dates
- 10 Jan 2020to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients has active endocarditis
- Patients has history of cerebral vascular accident or transient ischemic attack within the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site, 1 recruiting
- Recruiting
National Research Center for Cardiac Surgery
Astana, 010000
Abdurashid Mussayev, PhD, +77029997667, abdurashid.mussayev@gmail.com
Serik Alimbayev, PhD
About this study
Official title: 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.
Read the detailed description
Primary Objectives
- Prevalence of aortic stenosis in Kazakhstan regions
- 12 months survival of patients after TAVI
- Intra- and postoperative complications
- Conduction disorders after TAVI
- Left ventricle function after TAVI in patients with low ejection fraction
- Comparison of aortic route dimensions by 3D-TEE and MSCT
- 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transcatheter aortic valve implantation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve implantationDevice
Also called Surgical aortic valve replacement
Compare self expendable and balloon expendable valves
| Study group | Role | What they receive |
|---|---|---|
| Patients after transcatheter aortic valve replacement | Experimental | 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. Receives: Device: Transcatheter aortic valve implantation |
| Patients after surgical aortic valve replacement | Active comparator | 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. Receives: Device: Transcatheter aortic valve implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of death
12 month all-cause of mortality
Measured: 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%).
Measured: 1 year
Incidence of stroke
procedure associated stroke and 12 months
Measured: within 30 days and 12 months
Permanent pacemaker implantation
procedure associated AB block which is need for permanent pacemaker implantation
Measured: 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
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start10 Jan 2020
- Primary completion10 Jan 2021
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Cardiac Surgery, Kazakhstan
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Cardiovascular
- Responsible party
- Principal investigator, Abdurashid, National Research Center for Cardiac Surgery, Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874465
- Sponsor's protocol ID
- v. 1
- Other IDs
- ERP-2019-11795
- Status last verified
- Mar 2025
- First submitted
- 12 Oct 2020
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAVI Registry at the National Research Center for Cardiac Surgery, Astana, Kazakhstan
- ClinicalTrials.gov ID
- NCT06874465
- Acronym / sponsor ID
- v. 1
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Research Center for Cardiac Surgery, KazakhstanUniversity, hospital or other
- Collaborators
- Medtronic Cardiovascular
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Prevalence of aortic stenosis in Kazakhstan regions
- 12 months survival of patients after TAVI
- Intra- and postoperative complications
- Conduction disorders after TAVI
- Left ventricle function after TAVI in patients with low ejection fraction
- Comparison of aortic route dimensions by 3D-TEE and MSCT
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after transcatheter aortic valve replacement | Experimental | Device: Transcatheter aortic valve implantationPatients 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. |
| Patients after surgical aortic valve replacement | Active comparator | Device: Transcatheter aortic valve implantationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients has active endocarditis
- Patients has history of cerebral vascular accident or transient ischemic attack within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter aortic valve implantationAlso: Surgical aortic valve replacementCompare self expendable and balloon expendable valves | Device | Patients after surgical aortic valve replacement, Patients after transcatheter aortic valve replacement |
Primary outcome
Number of death
Time frame: 1 year
12 month all-cause of mortality
Evaluate of echocardiographic results
Time frame: 1 year
echocardiographic parameters: Aortic valve orifice area, aortic valve bioprosthetic gradient (peak, mean), aortic valve bioprosthetic velocity, ejection fracrion of left ventricle (LVEF%).
Incidence of stroke
Time frame: within 30 days and 12 months
procedure associated stroke and 12 months
Permanent pacemaker implantation
Time frame: within 30 days
procedure associated AB block which is need for permanent pacemaker implantation
1 secondary outcome
Life quality
Time frame: Baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Acute Pain
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter aortic valve implantation in people with Aortic Valve Stenosis, run by National Research Center for Cardiac Surgery, Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdurashid Mussayev, PhD (+77029997667, abdurashid.mussayev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of death (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.