Pilot Trial: Comparison of Flow Patterns

Aortic Valve Stenosis Clinical Trial

Official title:

Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02288871
• Other study ID #: 1790/2013-1
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2014
• Last updated: March 26, 2018
• Start date: October 2014
• Est. completion date: December 2021

Study information

• Verified date: March 2018
• Source: Medical University of Vienna
• Contact: Claus Rath, MD
• Phone: 0043-1-40400-69660
• Email: claus.rath[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Intervention

Radiation:
• Cardiac CT-scan
ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs). In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	University College, London

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of maximum and minimum velocity under patient specific conditions		between 6 months and 4 years after aortic valve replacement
Primary	Comparison of the effective orifice area under patient specific conditions		between 6 months and 4 years after aortic valve replacement
Primary	Comparison of the percentage of turbulent flow under patient specific conditions		between 6 months and 4 years after aortic valve replacement
Primary	Comparison of the pressure drop under patient specific conditions		between 6 months and 4 years after aortic valve replacement
Secondary	Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.	The first secondary outcome measure is the comparison of; -pressure gradients; as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified.; If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics."	between 6 months and 4 years after aortic valve replacement
Secondary	Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.	The second secondary outcome measure is the comparison of; -peak velocity; as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified.; If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics."	between 6 months and 4 years after aortic valve replacement