Clinical trial NCT06874465: Transcatheter Aortic Valve Implantation Registry at the National Research Center for Cardiac Surgery, Nur-Sultan, Kazakhstan
Official title: TAVI Registry at the National Research Center for Cardiac Surgery, Astana, Kazakhstan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: National Research Center for Cardiac Surgery, Kazakhstan
Sponsor class: OTHER
Collaborators: name: Medtronic Cardiovascular
First posted: 2025-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of death
timeFrame: 1 year
measure: Evaluate of echocardiographic results
timeFrame: 1 year
measure: Incidence of stroke
timeFrame: within 30 days and 12 months
measure: Permanent pacemaker implantation
timeFrame: within 30 days
Secondary outcomes:
measure: Life quality
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: National Research Center for Cardiac Surgery
Study officials:
References: