NCT05308173

Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,393 (actual)
• Sponsor: Nicolaus Copernicus University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
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.
PROCEDURE	Transcutenous Aortic Valve Implantation	Transfemoral implantation of aortic bioprosthesis with one of the devices available in Poland.

Timeline

• Start date: 2015-01-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2022-04-01
• Last updated: 2022-04-01