NCT06874465

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

October 12, 2020

Last Update Submit

March 11, 2025

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (4)

  • Number of death

    12 month all-cause of mortality

    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%).

    1 year

  • Incidence of stroke

    procedure associated stroke and 12 months

    within 30 days and 12 months

  • Permanent pacemaker implantation

    procedure associated AB block which is need for permanent pacemaker implantation

    within 30 days

Secondary Outcomes (1)

  • Life quality

    Baseline, 12 months

Study Arms (2)

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.

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.

Device: Transcatheter aortic valve implantation

Interventions

Transcatheter aortic valve implantationDEVICE

Compare self expendable and balloon expendable valves

Also known as: Surgical aortic valve replacement
Patients after surgical aortic valve replacementPatients after transcatheter aortic valve replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Center for Cardiac Surgery

Astana, 010000, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Central Study Contacts

Abdurashid Mussayev, PhD

CONTACT

+77029997667abdurashid.mussayev@gmail.com

Sadyk Khamitov

CONTACT

+77055756439sadyk.kh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the department of the catheterization laboratory

Study Record Dates

First Submitted

October 12, 2020

First Posted

March 13, 2025

Study Start

January 10, 2020

Primary Completion

January 10, 2021

Study Completion

January 10, 2026

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

KA(1)