Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry (AVALON)
March 31, 2022 updated by: Mariusz Kowalewski, Nicolaus Copernicus University
Surgical and Transcatheter Aortic Valve Replacement for Aortic Stenosis in Low-risk Elective Patients. Data From Multicenter Registry.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
2393
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Age >18 years
- Elective procedure
- Aortic valve replacement with means of TAVI or SAVR
Exclusion Criteria:
- Concomitant procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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
|
Transfemoral implantation of aortic bioprosthesis with one of the devices available in Poland.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
all-cause death
Time Frame: up to 6 years
|
death resulting from cardiovascular and non-cardiovascular causes
|
up to 6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
March 20, 2022
First Submitted That Met QC Criteria
March 31, 2022
First Posted (Actual)
April 1, 2022
Study Record Updates
Last Update Posted (Actual)
April 1, 2022
Last Update Submitted That Met QC Criteria
March 31, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVALON
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.