- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01493284
Portico TAVI Implant With Transfemoral Delivery System
Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Leeuwarden, 네덜란드
- Medical Center Leeuwarden
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Copenhagen, 덴마크
- Rigshospitalet Copenhagen
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Bad Nauheim, 독일
- Kerckhoff Klinik
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Bernau, 독일
- Heart Center Bernau
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Hamburg, 독일
- Asklepios Klinik-St. Georg
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Jena, 독일
- Klinikum der Universität Jena
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Karlsruhe, 독일
- Klinik fur Herzhirurgie Karlruhe GmbH
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Leipzig, 독일
- Herzzentrum Leipzig
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Leicester, 영국
- Glenfield Hospital
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London, 영국
- St. Thomas' Hospital
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London, 영국
- Kings College
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Plymouth, 영국
- Derriford Hospital, Plymouth
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Northern Ireland
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Belfast, Northern Ireland, 영국, BT12 6BA
- Royal Victoria Hospital
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Adelaide, 호주
- Adelaide Royal Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subject has given written study Informed Consent for participation prior to procedure.
- Subject is ≥ 18 years of age or legal age in host country.
- Subject's aortic annulus diameter meets the range indicated in the Instructions for use as measured by echocardiogram (echo) or CT conducted within the past 90 days.
- Subject has senile degenerative aortic stenosis with echocardiography (echo) derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2). (Baseline measurement taken by echo within 30 days of procedure).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
- Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee (See Section 3.1 for the definition of the Subject Selection Committee)
- Subject's predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
- In the opinion of the Subject Selection Committee and based upon angiographic measurements, the subject has suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
- Subject has structurally normal cardiac anatomy.
- Subject is willing and able to comply with all required follow-up evaluations.
Exclusion Criteria:
- Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of the index procedure.
- Subject has carotid artery disease requiring intervention.
- Subject has evidence of a myocardial infarction (MI) within the past 6 months (≤180 days) of the index procedure.
- Subject has hypertrophic cardiomyopathy.
- Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- Subject has mitral or tricuspid valvular regurgitation (>grade III) or moderate to severe mitral stenosis.
- Subject has aortic root angulation >70 degrees (horizontal aorta).
- Subject has a pre-existing prosthetic valve or prosthetic ring in any position.
- Subject refuses blood transfusion or surgical valve replacement.
- Subject has left ventricular ejection fraction (LVEF) < 20%.
- The subject has documented, untreated coronary artery disease (CAD) requiring revascularization.
- Subject has severe basal septal hypertrophy.
- Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days of the index procedure.
- Subject has a history of or has active endocarditis.
- Subject has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Subject has hemodynamic instability (requiring inotropic support or mechanical heart assistance).
- Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
- Subject with significant pulmonary disease.
- Subject has significant chronic steroid use.
- Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- Subject has renal insufficiency as evidenced by a serum creatinine > 3.0 mg/dL (265µmol/L) or end-stage renal disease requiring chronic dialysis.
- Subject has morbid obesity defined as BMI ≥ 40.
- Subject's iliac arteries have severe calcification, tortuosity (>two 90 degree bends), diameter <6mm, or subject has had an aorto-femoral bypass.
- Subject has ongoing infection or sepsis.
- Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
- Subject has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
Subject has significant aortic disease, including:
- aortic abdominal aneurysm (AAA) ≥ 4cm
- thoracic aneurysm (defined as a maximal luminal diameter of 5 cm or greater)
- marked tortuosity
- significant aortic arch atheroma or narrowing of the abdominal or thoracic aorta
- severe tortuosity of the thoracic aorta.
- Subject has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
- Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to the index procedure.
- Subject is currently participating in another investigational drug or device study.
- Subject requires emergency surgery for any reason.
- Subject has a life expectancy < 12 months.
- Subject has other medical, social or psychological conditions that, in the opinion of the Subject Selection Committee, preclude the subject from study participation.
- Subject is suffering from dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
- Subject has a known allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Transfemoral Access
Transfemoral Access for transcatheter aortic valve implant
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Placement of the SJM Portico aortic valve with a transfemoral delivery system
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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All Cause Mortality
기간: 30 days
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Number of participants that reported all cause mortality
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30 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Select Cardiovascular Adverse Events
기간: 30 days
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Number of participants with select cardiovascular adverse events
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30 days
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Participant NYHA Classification at Day 30
기간: day 30
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The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256. |
day 30
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Number of Participants With Acute Device Success
기간: 7 days
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7 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ganesh Manoharan, MD, Royal Victoria Hospital
간행물 및 유용한 링크
일반 간행물
- Walther T, Manoharan G, Linke A, Mollmann H, Holzhey D, Worthley SG, Kim WK, Schafer U. Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico valve. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):467-474. doi: 10.1093/ejcts/ezy078.
- Linke A, Holzhey D, Mollmann H, Manoharan G, Schafer U, Frerker C, Worthley SG, van Boven AJ, Redwood S, Kovac J, Butter C, Sondergaard L, Lauten A, Schymik G, Walther T. Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study. Circ Cardiovasc Interv. 2018 Feb;11(2):e005206. doi: 10.1161/CIRCINTERVENTIONS.117.005206.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1105
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Transcatheter Aortic Valve Implantation에 대한 임상 시험
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Symetis SA완전한
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NVT GmbH모병경피적 대동맥 판막 이식핀란드, 스페인, 독일, 폴란드, 스위스
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NVT GmbH모병경피적 대동맥 판막 이식스페인, 독일