NCT04722796招募中不适用
HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy
Second Affiliated Hospital, School of Medicine, Zhejiang University19 个研究点 分布在 1 个国家目标入组 508 人开始时间: 2021年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 508
- 试验地点
- 19
- 主要终点
- Composite of all-cause mortality rate, disabling stroke rate, new permanent pacemaker implantation rate and moderate or severe prosthetic valve regurgitation rate at 1 month
研究概览
简要总结
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
详细描述
Transcatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for severe symptomatic aortic stenosis (AS) patients from low to high surgical risk. BAV patients treated with TAVR had similar 30-day mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.
Clinical experience in China suggests bicuspid aortic valves and heavy calcium burden are more common among TAVR candidates. Morphological characteristics at supra-annular structure (from annulus to the level of sinotubular junction) are quite complex in bicuspid AS, especially concomitant with heavily calcified leaflets. Because only two leaflet hinge points provide the definition of the annulus plane, current CT-based annulus measurements might not be accurate under these circumstances. From previous single center clinical practice, "waist sign" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in patients with bicuspid AS, indicating that the supra-annular structure may serve a key role in anchoring the THV.
Therefore, we developed a balloon based supra-annular sizing strategy (Hangzhou Solution) for SEV implantation in bicuspid AS. From our single center experience, the device success rate and pacemaker implantation rate were relatively low.
The aim of this study is to compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and ourcome assessor are blind to treatment groups.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Age <65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;
- •Severe, bicuspid aortic stenosis:
- •Mean gradient ≥40 mmHg
- •Maximal aortic valve velocity ≥4.0 m/sec
- •Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2)
- •NYHA classification ≥ II;
- •Type 0, type 1 (Sievers classification) by MDCT
- •Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm;
- •Transfemoral TAVR
- •The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
排除标准
- •Any contra-indication for Self-expanding bioprosthetic aortic valve deployment
- •Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt< 50,000 cell/mL).
- •Active sepsis, including active bacterial endocarditis with or without treatment;
- •Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
- •Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
- •Estimated life expectancy < 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
- •Any Emergent surgery required before TAVR procedure.
- •A known hypersensitivity or contraindication to any of the following that cannot be adequately medicated:aspirin or heparin (HIT/HITTS) and bivalirudin, clopidogrel,Nitinol (titanium or nickel),contrast media
- •Gastrointestinal (GI) bleeding that would preclude anticoagulation.
- •Subject refuses a blood transfusion.
- •Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
- •Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams.
- •Currently participating in an investigational drug or another device study (excluding registries).
- •Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM).
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- •Severe mitral stenosis amenable to surgical replacement or repair.
- •Aortic valve type cannot be determined (Sievers classification).
- •Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe"unfolding" and horizontal aorta(Annular Angulation>70°).
- •Ascending aorta diameter > 50 mm.
- •Aortic or iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- •Patient is considered high risk for TAVR by CT corelab, including coronary obstruction, annular rupture and other severe TAVR-Related complications.
- •Previous pacemaker implantation.
结局指标
主要结局
Composite of all-cause mortality rate, disabling stroke rate, new permanent pacemaker implantation rate and moderate or severe prosthetic valve regurgitation rate at 1 month
时间窗: 1 month
Composite of all-cause mortality, disabling stroke, new permanent pacemaker implantation and moderate or severe prosthetic valve regurgitation at 1 month (per Valve Academic Research Consortium-2 \[VARC-2\] criteria)
次要结局
- Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 4 years(4 years)
- Rate of alternating valve of prosthetic valve size during TAVR(peri-procedural)
- Deaths (all-cause mortality) at 1 month(1 month)
- Deaths (all-cause mortality) at 2 years(2 years)
- All Stroke (disabling and non-disabling) at 4 years(4 years)
- Rate of Moderate or severe prosthetic valve regurgitation at 5 years(5 years)
- Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 month(1 month)
- Rate of device recapture or retrieval(peri-procedural)
- Deaths (all-cause mortality) at 3 years(3 years)
- All Stroke (disabling and non-disabling) at 1 month(1 month)
- All Stroke (disabling and non-disabling) at 5 years(5 years)
- Rate of New permanent pacemaker implantation at 2 years(2 years)
- Rate of Moderate or severe prosthetic valve regurgitation at 3 years(3 years)
- Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 year(1 year)
- Rate of New permanent pacemaker implantation at 1 month(1 month)
- Rate of New permanent pacemaker implantation at 1 year(1 year)
- Rate of New permanent pacemaker implantation at 3 years(3 years)
- Rate of Moderate or severe prosthetic valve regurgitation at 1 month(1 month)
- Rate of Moderate or severe prosthetic valve regurgitation at 2 years(2 years)
- Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 5 years(5 years)
- Rate of conversion to open surgery(peri-procedural)
- Rate of annulus rupture(peri-procedural)
- New onset complete LBBB before discharge(before discharge)
- New onset complete LBBB at 1 month(1 month)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 1 month(1 month)
- Deaths (all-cause mortality) at 4 years(4 years)
- All Stroke (disabling and non-disabling) at 3 years(3 years)
- Rate of New permanent pacemaker implantation at 4 years(4 years)
- Rate of New permanent pacemaker implantation at 5 years(5 years)
- Rate of unplanned use of cardiopulmonary bypass (CPB) for hemodynamic support at any time during the TAVR procedure(peri-procedural)
- Rate of structural valve deterioration at 1 month(1 month)
- Rate of structural valve deterioration at 1 year(1 year)
- Rate of structural valve deterioration at 3 years(3 years)
- Rate of structural valve deterioration at 4 years(4 years)
- Deaths (all-cause mortality) at 1 year(1 year)
- Deaths (all-cause mortality) at 5 years(5 years)
- All Stroke (disabling and non-disabling) at 1 year(1 year)
- All Stroke (disabling and non-disabling) at 2 years(2 years)
- Rate of Moderate or severe prosthetic valve regurgitation at 1 year(1 year)
- Rate of Moderate or severe prosthetic valve regurgitation at 4 years(4 years)
- Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 2 years(2 years)
- Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 3 years(3 years)
- Rate of valve malposition(peri-procedural)
- Rate of TAV-in-TAV deployment(peri-procedural)
- Rate of coronary obstruction(peri-procedural)
- Major vascular complications (VARC 2)(peri-procedural)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 1 year(1 year)
- New York Heart Association (NYHA) Functional Class at 1 month(1 month)
- New York Heart Association (NYHA) Functional Class at 5 years(5 years)
- Six Minute Walk Test (6MWT Distance or 6MWD) at 1 year(1 year)
- Six Minute Walk Test (6MWT Distance or 6MWD) at 5 years(5 years)
- Mini-Mental State Examination score at 1 month(1 month)
- Rate of structural valve deterioration at 2 years(2 years)
- Rate of structural valve deterioration at 5 years(5 years)
- New York Heart Association (NYHA) Functional Class at 1 year(1 year)
- New York Heart Association (NYHA) Functional Class at 4 years(4 years)
- Six Minute Walk Test (6MWT Distance or 6MWD) at baseline(Baseline)
- Six Minute Walk Test (6MWT Distance or 6MWD) at 4 years(4 years)
- Mini-Mental State Examination score at baseline(baseline)
- Mini-Mental State Examination score at 2 years(2 years)
- Mini-Mental State Examination score at 5 years(5 years)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at Baseline(Baseline)
- Mini-Mental State Examination score at 1 year(1 year)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 2 years(2 years)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 3 years(3 years)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 4 years(4 years)
- New York Heart Association (NYHA) Functional Class at baseline(Baseline)
- Mini-Mental State Examination score at 3 years(3 years)
- Mini-Mental State Examination score at 4 years(4 years)
- Modified Rankin Scale Score at 2 years(2 years)
- Modified Rankin Scale Score at 3 years(3 years)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 5 years(5 years)
- New York Heart Association (NYHA) Functional Class at 2 years(2 years)
- New York Heart Association (NYHA) Functional Class at 3 years(3 years)
- Six Minute Walk Test (6MWT Distance or 6MWD) at 1 month(1 month)
- Six Minute Walk Test (6MWT Distance or 6MWD) at 2 years(2 years)
- Six Minute Walk Test (6MWT Distance or 6MWD) at 3 years(3 years)
- Modified Rankin Scale Score at 4 years(4 years)
- Modified Rankin Scale Score at 5 years(5 years)
- Modified Rankin Scale Score at baseline(baseline)
- Modified Rankin Scale Score at 1 month(1 month)
- Modified Rankin Scale Score at 1 year(1 year)
研究者
研究点 (19)
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