Pilot Trial: Comparison of Flow Patterns

Medical University of Vienna

Status: Unknown

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Treatments: Radiation: Cardiac CT-scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02288871

1790/2013-1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

"Sutureless" valve

Other group

Description:

Patients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.

Treatment:

Radiation: Cardiac CT-scan

"Sewed-in" valve

Other group

Description:

Patients who underwent aortic valve replacement with a "sewed-in" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.

Treatment:

Radiation: Cardiac CT-scan