Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry (AVALON)

Nicolaus Copernicus University

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Procedure: Transcutenous Aortic Valve Implantation; Procedure: Surgical Aortic Valve Replacement

Study type: Observational

Funder types: Other

Identifiers

NCT05308173

AVALON

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,393 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Concomitant procedures

Trial design

2,393 participants in 2 patient groups

Surgical Aortic Valve Replacement

Description:

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.

Treatment:

Procedure: Surgical Aortic Valve Replacement

Transcutaneous Aortic Valve Implantation

Description:

Transfemoral aortic valve implantation. Patients with a planned concomitant percutaneous coronary intervention were excluded

Treatment:

Procedure: Transcutenous Aortic Valve Implantation