Status:
UNKNOWN
Pilot Trial: Comparison of Flow Patterns
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
University College, London
Conditions:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02288871
Start Date
October 1 2014
End Date
December 1 2021
Last Update
March 27 2018
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090