Pilot Trial: Comparison of Flow Patterns

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

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 Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency
• Intervention / Treatment: Radiation: Cardiac CT-scan

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claus Rath, MD; Phone Number: 0043-1-40400-69660; Email: claus.rath@meduniwien.ac.at
• Study Contact Backup: Name: Martin Andreas, MD; Phone Number: 0043-1-40400-69660; Email: martin.andreas@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Claus Rath, MD; Phone Number: 0043-1-40400-69660; Email: claus.rath@meduniwien.ac.at
    • Contact: Alfred Kocher, MD; Phone Number: 0043-1-40400-69660; Email: alfred.kocher@meduniwien.ac.at
    • Principal Investigator: Alfred Kocher, MD
    • Sub-Investigator: Claus Rath, MD
    • Sub-Investigator: Martin Andreas, MD
    • Sub-Investigator: Dominik Wiedemann, MD
    • Sub-Investigator: Guenther Laufer, MD
    • Sub-Investigator: Christian Loewe, MD
    • Sub-Investigator: Raphael Rosenhek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: "Sutureless" valve; Patients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.	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.
Other: "Sewed-in" valve; Patients who underwent aortic valve replacement with a "sewed-in" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of maximum and minimum velocity under patient specific conditions	between 6 months and 4 years after aortic valve replacement
Comparison of the effective orifice area under patient specific conditions	between 6 months and 4 years after aortic valve replacement
Comparison of the percentage of turbulent flow under patient specific conditions	between 6 months and 4 years after aortic valve replacement
Comparison of the pressure drop under patient specific conditions	between 6 months and 4 years after aortic valve replacement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: University College, London
• Investigators: Principal Investigator: Alfred Kocher, MD, Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: aortic valve replacement; aortic valve bioprosthesis; hemodynamics
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: 1790/2013-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No