Prospective, Multicenter, Single-arm, Open-label Study Evaluating the Safety and Effectiveness of the Myval Transcatheter Heart Valve (THV) System in High-risk Patients With Severe Symptomatic Non- or Mildly Calcified Aortic Regurgitation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Ceric Sàrl
- 入组人数
- 164
- 主要终点
- All Stroke
研究概览
简要总结
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
详细描述
Severe symptomatic aortic regurgitation (AR) in high-risk or inoperable patients with non- or mildly calcified valves has limited treatment options. While TAVR has emerged as a viable approach in aortic stenosis, its use in aortic regurgitation remains limited due to anatomical complexities, the absence of dedicated devices, and the prevalence of large annular dimensions in these patients.Dedicated devices like the JenaValve Trilogy™ demonstrated safety and efficacy in trials such as ALIGN-AR and JUPITER registry, but use is restricted by annular size limitations.Additionally, The PANTHEON International Project demonstrated safety and efficacy of balloon and self-expandable valves in severe AR patients. Despite improved THV platforms and techniques, TAVR for pure native aortic valve regurgitation remains a challenging procedure, with significant risk for transcatheter valve embolization or migration (TVEM).The Myval THV series offers a broader size range from 20mm-35mm and allows for controlled oversizing, as demonstrated in a large international registry showing high technical success and favorable 1-year outcomes in patients with non-calcified AR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient above 18 years of age.
- •Patients must have co-morbidities such that the heart team and Investigator concur that the predicted risk of operative mortality is high.
- •Patient has non- or mild-calcified aortic regurgitation, undergoing TAVI with Myval THV Series without any degree stenosis, and severe aortic regurgitation as per investigator/ Heart team discretion according to (at least one) imaging criteria that can include:
- •Echocardiographically derived criteria: regurgitant volume ≥60 ml/beat, regurgitant fraction ≥50%, effective regurgitant orifice ≥0.3cm2, holodiastolic flow reversal at the level of the mid-descending aorta with an end diastolic flow velocity greater than 20 cm/s, width of vena contracta ≥6mm, hemi pressure time <200 msec, or vena contracta area assessed with 3D echo ≥0.4 cm².
- •Cardiac magnetic resonance derived criteria: Regurgitant fraction >40% or regurgitant volume >60mL.
- •Patient suitable for implantation with Myval THV series via transfemoral approach.
- •Patient is symptomatic from his/her aortic valve regurgitation, as demonstrated by the New York Heart Association (NYHA) Functional Class ≥II.
- •Patient or the patient's legal representative 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 of the respective clinical site.
- •The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.
排除标准
- •Patients who are not willing to provide informed consent form, or whose legal heirs object to participate in the study
- •Pregnant and lactating female patients
- •Evidence of an acute myocardial infarction ≤1 month before the intended treatment
- •Mixed aortic valve disease
- •Moderate-severe calcification of aortic valve
- •Bicuspid aortic valve disease according to treating physician (if detected by the corelab it will not be excluded except if so considered by the steering committee)
- •Congenital unicuspid patients
- •Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent/scaffold implantation).
- •Pre-existing prosthetic heart valve in any position, prosthetic ring, severe mitral annular calcification (MAC), severe (greater than 3+) mitral insufficiency, or Gorlin syndrome.
- •Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg/dl), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
- •Untreated clinically significant coronary artery disease requiring revascularization.
- •Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- •Need for emergency surgery other than aortic valve replacement with the study device.
- •Hypertrophic cardiomyopathy with or without obstruction (HOCM).
- •Very severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <15%.
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- •Active peptic ulcer or upper GI bleeding within the prior 3 months.
- •A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated.
- •Recent (within 6 months) cerebrovascular accident (CVA) or a Transient Ischemic Attack (TIA).
- •Renal insufficiency and/or end stage renal disease requiring chronic dialysis
- •Life expectancy <1 year due to non-cardiac co-morbid conditions.
- •Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only) which would make Transcatheter Aortic Valve Implantation (TAVI) unfeasible as per the Investigator/Heart Team.
- •Iliofemoral vessel characteristics that would preclude safe placement of introducer sheath such as severe obstructive calcification, severe tortuosity or vessels with adequate femoral size (applicable for transfemoral patients only).
- •Currently participating in an investigational drug or another device study which has not achieved the primary endpoint.
- •Active bacterial endocarditis or other active infections.
- •Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
研究组 & 干预措施
Single Arm
All patients with severe symptomatic non- or mild-calcified aortic regurgitation undergoing TAVR using Myval THV series in high surgical risk based on investigator/Heart team discretion who meet study eligibility criteria.
干预措施: Myval THV series (Device)
结局指标
主要结局
All Stroke
时间窗: 30 days
Any ischemic or hemorrhagic stroke confirmed by clinical evaluation and/or appropriate imaging during follow-up.
All cause mortality
时间窗: 30 days
Death due to any cause occurring during the specified follow-up period.
Bleeding (Type 3 & 4)
时间窗: 30 days
Major bleeding events classified as Bleeding Academic Research Consortium (BARC) Type 3 or Type 4.
Major vascular complications
时间窗: 30 days
Major vascular access- or procedure-related complications as defined by the Valve Academic Research Consortium (VARC) criteria.
Acute Kidney Injury (Stage 3 and 4)
时间窗: 30 days
Acute kidney injury meeting Stage 3 or Stage 4 severity according to the applicable VARC/AKI classification criteria.
Surgery/Intervention related to device
时间窗: 30 days
Any unplanned surgical or catheter-based intervention performed to correct or treat a device-related complication.
Conduction system disturbances resulting in a new permanent pacemaker implantation
时间窗: 30 days
New conduction abnormalities requiring implantation of a permanent pacemaker after the index procedure.
Greater than or equal to Moderate Paravalvular Regurgitation
时间窗: 30 days
Presence of moderate or severe paravalvular regurgitation as determined by echocardiographic assessment during follow-up.
次要结局
- All cause mortality(6 months, 1 year, 2 years, 3 years, 4 years and 5 years)
- All Stroke(1 years, 3 years and 5 years)
- Bleeding (Type 3 & 4)(1 year, 3 years and 5 years)
- Surgery/Intervention related to device(1 year, 3 years and 5 years)
- Conduction system disturbances resulting in a new permanent pacemaker implantation(1 year, 3 years and 5 years)
- Re-hospitalization for procedure-related or valve-related causes(30 days, 1 year, 3 years and 5 years)
- NYHA functional improvement(30 days, 1 year, 3 years and 5 years)
- Residual aortic regurgitation ≤ mild(30 days, 1 year, 3 years and 5 years)
- Six-minute walk test(30 days, 1 year, 3 years and 5 years)
- Evidence of bioprosthetic valve dysfunction and bioprosthetic valve failure(1 year, 3 year and 5 year)
- Bioprosthetic valve deterioration(1 year)
- Length of index hospital stay(From procedure up to discharge, assessed until 2-3 days post procedure)
- Improved KCCQ from baseline(30 days, 1 year, 3 years and 5 years)
- Improved EQ-5D from baseline(30 days, 1 year, 3 years and 5 years)
- Improved valve function(30 days, 1 year, 3 years and 5 years)
- Technical success at exit from procedure(30 days)
- Device Success(30 days)