Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: Surgical Aortic Valve Replacement; Procedure: Transcutenous Aortic Valve Implantation

• Registration Number: NCT05308173
• Lead Sponsor: Nicolaus Copernicus University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-03
• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2393

Inclusion Criteria

• Age >18 years
• Elective procedure
• Aortic valve replacement with means of TAVI or SAVR

Exclusion Criteria

• Concomitant procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical Aortic Valve Replacement	Surgical Aortic Valve Replacement	Surgically replaced aortic valve. Patients with planned concomitant bypass grafting other valvular interventions, arrhythmia ablation, or left atrial appendage occlusion were excluded. Any tissue or mechanical valve implantation in an aortic position with sternotomy or minimal access was included.
Transcutaneous Aortic Valve Implantation	Transcutenous Aortic Valve Implantation	Transfemoral aortic valve implantation. Patients with a planned concomitant percutaneous coronary intervention were excluded

Primary Outcome Measures

Name	Time	Method
all-cause death	up to 6 years	death resulting from cardiovascular and non-cardiovascular causes