Clinical trial NCT02288871: 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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Insufficiency
Keywords: aortic valve replacement
aortic valve bioprosthesis
hemodynamics
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2014-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Comparison of maximum and minimum velocity under patient specific conditions
timeFrame: between 6 months and 4 years after aortic valve replacement
measure: Comparison of the effective orifice area under patient specific conditions
timeFrame: between 6 months and 4 years after aortic valve replacement
measure: Comparison of the percentage of turbulent flow under patient specific conditions
timeFrame: between 6 months and 4 years after aortic valve replacement
measure: Comparison of the pressure drop under patient specific conditions
timeFrame: between 6 months and 4 years after aortic valve replacement
Secondary outcomes:
measure: Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
timeFrame: between 6 months and 4 years after aortic valve replacement
measure: Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.
timeFrame: between 6 months and 4 years after aortic valve replacement
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna
name: Alfred Kocher, MD
role: PRINCIPAL_INVESTIGATOR
References: