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

National Research Center for Cardiac Surgery, Kazakhstan

Status: Enrolling

Conditions: Aortic Valve Stenosis

Treatments: Device: Transcatheter aortic valve implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06874465

v. 1

ERP-2019-11795 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Patients after transcatheter aortic valve replacement

Experimental group

Description:

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.

Treatment:

Device: Transcatheter aortic valve implantation

Patients after surgical aortic valve replacement

Active Comparator group

Description:

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.

Treatment:

Device: Transcatheter aortic valve implantation