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NCT05308173 Clinical Trial

Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry

Aortic Valve Stenosis Clinical Trial

— AVALON  

Official title:
Surgical and Transcatheter Aortic Valve Replacement for Aortic Stenosis in Low-risk Elective Patients. Data From Multicenter Registry.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05308173
Other study ID # AVALON
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date June 30, 2021

Study information
Verified date March 2022
Source Nicolaus Copernicus University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multicenter registry data analysis of aortic valve stenosis patients that underwent elective, isolated transcutaneous aortic valve implantation (TAVI) or surgical aortic valve replacement between 2015 and 2019. In TAVI group only transfemoral access was considered.

Description:

A retrospective analysis of the Multicenter Aortic Valve Registry patients operated between 2015 and 2019 in the three departments of cardiac surgery in Poland: the Medical University of Silesia in Katowice, Medical University in Gdańsk, and Poznań, University of Medical Science. Baseline clinical, procedural, and outcome data at follow-up were entered into prespecified electronic case report forms. Follow-up status was validated by personal contact or access to Polish National Health Fund. Patients with planned concomitant intervention on coronary arteries (by bypass grafting or percutaneous intervention), other valvular interventions, arrhythmia ablation, or left atrial appendage occlusion were excluded too. In TAVI group only femoral access was considered. For SAVR any tissue or mechanical valve implantation in an aortic position with sternotomy or minimal access was included.

Recruitment information / eligibility
Status Completed
Enrollment 2393
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >18 years - Elective procedure - Aortic valve replacement with means of TAVI or SAVR Exclusion Criteria: - Concomitant procedures

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgical Aortic Valve Replacement
Cardiac surgery under cardio-pulmonary bypass, via sternotomy or minimally invasive approach with the replacement of native valve with a biological or mechanic prosthesis.
• Transcutenous Aortic Valve Implantation
Transfemoral implantation of aortic bioprosthesis with one of the devices available in Poland.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nicolaus Copernicus University

Outcome
Type Measure Description Time frame Safety issue
Primary all-cause death death resulting from cardiovascular and non-cardiovascular causes up to 6 years
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