Brief Title
Pilot Trial: Comparison of Flow Patterns
Official Title
Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?
Brief Summary
The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement. Our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.
Study Type
Interventional
Primary Outcome
Comparison of maximum and minimum velocity under patient specific conditions
Secondary Outcome
Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
Condition
Aortic Valve Stenosis
Intervention
Cardiac CT-scan
Study Arms / Comparison Groups
"Sutureless" valve
Description: Patients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
20
Start Date
October 2014
Completion Date
December 2021
Primary Completion Date
December 2020
Eligibility Criteria
Inclusion Criteria: - Patient underwent open aortic valve replacement with either an Edwards Magna Ease or an Edwards Intuity valve - Implanted valve size 23mm - Surgical access via full sternotomy or hemisternotomy - Intuity Valve System implanted by one of the clinical investigators of the TRITON trial (http://clinicaltrials.gov/show/NCT01445171) at the Medical University of Vienna - Post-operative ejection fraction ≥50% - Sinus-Rhythm - Ability to understand and comply with study procedures - Signed informed consent Exclusion Criteria: - Under 18 years of age - Emergency surgery - Pregnancy - Previous aortic root replacement - Previous aortic valve replacement - Previous or concomitant root enlargement - Previous or concomitant repair of the ascending aorta - Paravalvular leakage - Ectasia of the ascending aorta - Previous or concomitant myomectomy - Concomitant replacement or repair of valves other than aortic - Usage of more than 3 sutures for implantation of the Intuity Valve System - Heavily calcified aortic root - Glomerular filtration rate (GFR) < 30 ml/min - Inability to understand or comply with study procedures - Known allergic reaction to iodinated, non-ionic contrast agents
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Alfred Kocher, MD, 0043-1-40400-69660, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02288871
Organization ID
1790/2013-1
Responsible Party
Principal Investigator
Study Sponsor
Medical University of Vienna
Collaborators
University College, London
Study Sponsor
Alfred Kocher, MD, Principal Investigator, Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna
Verification Date
March 2018