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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05308173
Acronym
AVALON
Enrollment
2393
Registered
2022-04-01
Start date
2015-01-01
Completion date
2021-06-30
Last updated
2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

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.

Interventions

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

PROCEDURETranscutenous Aortic Valve Implantation

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

Sponsors

Nicolaus Copernicus University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Concomitant procedures

Design outcomes

Primary

MeasureTime frameDescription
all-cause deathup to 6 yearsdeath resulting from cardiovascular and non-cardiovascular causes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026