AVALON: Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry

Sponsor

Nicolaus Copernicus University (Other)

Overall Status

Completed

CT.gov ID

NCT05308173

Collaborator

(none)

2,393

Enrollment

77.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Procedure: Surgical Aortic Valve Replacement Procedure: Transcutenous Aortic Valve Implantation

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 Design

Study Type:

Observational

Actual Enrollment :

2393 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
Transcutaneous Aortic Valve Implantation Transfemoral aortic valve implantation. Patients with a planned concomitant percutaneous coronary intervention were excluded	Procedure: Transcutenous Aortic Valve Implantation Transfemoral implantation of aortic bioprosthesis with one of the devices available in Poland.

Arm

Intervention/Treatment

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.

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.

Transcutaneous Aortic Valve Implantation

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

Procedure: Transcutenous Aortic Valve Implantation

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

Outcome Measures

Primary Outcome Measures

all-cause death [up to 6 years]
death resulting from cardiovascular and non-cardiovascular causes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Concomitant procedures

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nicolaus Copernicus University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mariusz Kowalewski, PhD, M.D., Nicolaus Copernicus University

ClinicalTrials.gov Identifier:

NCT05308173

Other Study ID Numbers:

AVALON

First Posted:

Apr 1, 2022

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Aortic Valve Stenosis

Constriction, Pathologic

Study Results

No Results Posted as of Apr 1, 2022