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Pilot Trial: Comparison of Flow Patterns

Primary Purpose

Aortic Valve Stenosis, Aortic Valve Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cardiac CT-scan
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aortic Valve Stenosis focused on measuring aortic valve replacement, aortic valve bioprosthesis, hemodynamics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

"Sutureless" valve

"Sewed-in" valve

Arm Description

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

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

Outcomes

Primary Outcome Measures

Comparison of maximum and minimum velocity under patient specific conditions
Comparison of the effective orifice area under patient specific conditions
Comparison of the percentage of turbulent flow under patient specific conditions
Comparison of the pressure drop under patient specific conditions

Secondary Outcome Measures

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."
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."

Full Information

First Posted
October 22, 2014
Last Updated
March 26, 2018
Sponsor
Medical University of Vienna
Collaborators
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02288871
Brief Title
Pilot Trial: Comparison of Flow Patterns
Official Title
Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
University College, London

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Aortic Valve Insufficiency
Keywords
aortic valve replacement, aortic valve bioprosthesis, hemodynamics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Sutureless" valve
Arm Type
Other
Arm Description
Patients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.
Arm Title
"Sewed-in" valve
Arm Type
Other
Arm Description
Patients who underwent aortic valve replacement with a "sewed-in" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.
Intervention Type
Radiation
Intervention Name(s)
Cardiac CT-scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of maximum and minimum velocity under patient specific conditions
Time Frame
between 6 months and 4 years after aortic valve replacement
Title
Comparison of the effective orifice area under patient specific conditions
Time Frame
between 6 months and 4 years after aortic valve replacement
Title
Comparison of the percentage of turbulent flow under patient specific conditions
Time Frame
between 6 months and 4 years after aortic valve replacement
Title
Comparison of the pressure drop under patient specific conditions
Time Frame
between 6 months and 4 years after aortic valve replacement
Secondary Outcome Measure Information:
Title
Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
Description
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."
Time Frame
between 6 months and 4 years after aortic valve replacement
Title
Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.
Description
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."
Time Frame
between 6 months and 4 years after aortic valve replacement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claus Rath, MD
Phone
0043-1-40400-69660
Email
claus.rath@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Andreas, MD
Phone
0043-1-40400-69660
Email
martin.andreas@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred Kocher, MD
Organizational Affiliation
Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Rath, MD
Phone
0043-1-40400-69660
Email
claus.rath@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Alfred Kocher, MD
Phone
0043-1-40400-69660
Email
alfred.kocher@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Alfred Kocher, MD
First Name & Middle Initial & Last Name & Degree
Claus Rath, MD
First Name & Middle Initial & Last Name & Degree
Martin Andreas, MD
First Name & Middle Initial & Last Name & Degree
Dominik Wiedemann, MD
First Name & Middle Initial & Last Name & Degree
Guenther Laufer, MD
First Name & Middle Initial & Last Name & Degree
Christian Loewe, MD
First Name & Middle Initial & Last Name & Degree
Raphael Rosenhek, MD

12. IPD Sharing Statement

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Pilot Trial: Comparison of Flow Patterns

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