Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry

NCT05308173 | Completed

• 1 other identifier: AVALON
• Study Type: observational
• Target: 2,393
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• all-cause death

  death resulting from cardiovascular and non-cardiovascular causes

  up to 6 years

Study Arms (2)

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

Transcutaneous Aortic Valve Implantation

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

Procedure: Transcutenous Aortic Valve Implantation

Interventions

Surgical Aortic Valve Replacement 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.

Surgical Aortic Valve Replacement

Transcutenous Aortic Valve Implantation PROCEDURE

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

Transcutaneous Aortic Valve Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective aortic valve replacement (AVR) for severe AS, regardless of the aortic regurgitation (AR) severity.

You may qualify if:

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

You may not qualify if:

• Concomitant procedures

Sponsors & Collaborators

• Nicolaus Copernicus University: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, M.D.

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: April 1, 2022
• Study Start: January 1, 2015
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share