Pilot Trial: Comparison of Flow Patterns

NCT02288871 | Unknown

• 1 other identifier: 1790/2013-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

aortic valve replacement; aortic valve bioprosthesis; hemodynamics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.

  between 6 months and 4 years after aortic valve replacement

• Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.

  between 6 months and 4 years after aortic valve replacement

Study Arms (2)

"Sutureless" valve

OTHER

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

"Sewed-in" valve

OTHER

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

Interventions

Cardiac CT-scan 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; "Sutureless" valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• University College, London: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Alfred Kocher, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claus Rath, MD

CONTACT

0043-1-40400-69660; claus.rath@meduniwien.ac.at

Martin Andreas, MD

CONTACT

0043-1-40400-69660; martin.andreas@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: November 11, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

AU (1)