Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2393 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Surgical Aortic Valve Replacement

Intervention Type PROCEDURE

Cardiac surgery under cardio-pulmonary bypass, via sternotomy or minimally invasive approach with the replacement of native valve with a biological or mechanic prosthesis.

Transcutaneous Aortic Valve Implantation

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

Transcutenous Aortic Valve Implantation

Intervention Type PROCEDURE

Transfemoral implantation of aortic bioprosthesis with one of the devices available in Poland.

Interventions

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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.

Intervention Type PROCEDURE