Pilot Trial: Comparison of Flow Patterns

NCT ID: NCT02288871

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2021-12-31

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

"Sutureless" valve

Patients who underwent aortic valve replacement with a "sutureless" aortic valve.

An echocardiogram and a cardiac CT-scan will be conducted.

Group Type: OTHER

Cardiac CT-scan

Intervention Type: RADIATION

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.

"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.

Group Type: OTHER

Cardiac CT-scan

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Alfred A Kocher, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alfred Kocher, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Claus Rath, MD

Role: CONTACT

claus.rath@meduniwien.ac.at

0043-1-40400-69660

Martin Andreas, MD

Role: CONTACT

martin.andreas@meduniwien.ac.at

0043-1-40400-69660

Facility Contacts

Claus Rath, MD

Role: primary

claus.rath@meduniwien.ac.at

0043-1-40400-69660

Alfred Kocher, MD

Role: backup

alfred.kocher@meduniwien.ac.at

0043-1-40400-69660

Other Identifiers

1790/2013-1

Identifier Type: -

Identifier Source: org_study_id