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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Vienna, 오스트리아, 1090
- 모병
- Medical University of Vienna
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연락하다:
- Claus Rath, MD
- 전화번호: 0043-1-40400-69660
- 이메일: claus.rath@meduniwien.ac.at
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연락하다:
- Alfred Kocher, MD
- 전화번호: 0043-1-40400-69660
- 이메일: alfred.kocher@meduniwien.ac.at
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수석 연구원:
- Alfred Kocher, MD
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부수사관:
- Claus Rath, MD
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부수사관:
- Martin Andreas, MD
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부수사관:
- Dominik Wiedemann, MD
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부수사관:
- Guenther Laufer, MD
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부수사관:
- Christian Loewe, MD
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부수사관:
- Raphael Rosenhek, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: "Sutureless" valve
Patients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted. |
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. |
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다른: "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.
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Comparison of maximum and minimum velocity under patient specific conditions
기간: between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
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Comparison of the effective orifice area under patient specific conditions
기간: between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
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Comparison of the percentage of turbulent flow under patient specific conditions
기간: between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
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Comparison of the pressure drop under patient specific conditions
기간: between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
기간: between 6 months and 4 years after aortic valve replacement
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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
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Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.
기간: between 6 months and 4 years after aortic valve replacement
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Alfred Kocher, MD, Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1790/2013-1
약물 및 장치 정보, 연구 문서
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