NCT07524595尚未招募不适用
Randomised Comparison of Self-Expanding Hydra THV Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis: REVIVAL Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Mean pressure gradient across the aortic valve.
研究概览
简要总结
This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic bioprosthesis. A total of 111 patients will be randomized in a 2:1 ratio, with 74 patients assigned to self-expanding Hydra THV Series and 37 patients assigned to BEV (Sapien THV Series and MyVal THV Series).
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
- 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
- •"Inclusion Criteria":
- •Male or Female patient ≥18 years of age
- •Severe hemodynamic valve deterioration of a surgically implanted bioprosthetic aortic valve, including severe valve stenosis and/or severe valve regurgitation, as determined by the Heart Team assessment
- •Patients eligible for transfemoral TAVI with both study THV platforms per heart team consensus.
- •TAVI (with or without fracture of surgical valve) is suitable with commercially available sizes of both Hydra and Sapien/Myvall BEVs.
- •Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee and is willing to comply with all protocol-required (follow-up) evaluations.
排除标准
- •Patients unwilling to provide an informed consent, or whose legal representative object to their participation in the study
- •Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in woman of child-bearing potential according to local practice)
- •Patients with non-transfemoral TAVI access.
- •Surgical or transcatheter valve in mitral position (mitral rings are not an exclusion)
- •Patients who had received the Bentall procedure.
- •Patients with active bacterial endocarditis or ongoing sepsis ≤6 months prior to the index procedure
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- •Acute myocardial infarction ≤30 days before the intended TAVI procedure
- •Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
- •Patients with severe left ventricular dysfunction and ejection fraction <30% or hemodynamic instability requiring inotropic agent or mechanical support.
- •Patients with significant renal insufficiency (serum creatinine >3.0 mg/dL (265.5μmol/L)) and/or end stage renal disease requiring chronic dialysis
- •Patients who are at very high risk of coronary obstruction (e.g., VIVID classification IIB, IIIB, IIIC) and are judged by the heart team to require upfront leaflet laceration (e.g. Basilica or Unicorn procedure) or chimney or snorkel stenting as part of the TAVI procedure.
- •Any planned surgical or peripheral procedure to be performed in next 30-day after the index procedure
- •Life expectancy <12 months due to non-cardiac co-morbid conditions including carcinomas, chronic liver disease, chronic renal disease or chronic end-stage pulmonary disease
研究组 & 干预措施
Hydra THV Series
Experimental
Self-expanding THV
干预措施: Hydra THV Series (Device)
Sapien THV Series, MyVal THV Series
Active Comparator
Balloon-expandable THV
干预措施: Sapien THV Series and MyVal THV Series (Device)
结局指标
主要结局
Mean pressure gradient across the aortic valve.
时间窗: 30 Days
The objective is to demonstrate that the self-expanding Hydra THV series is non-inferior, and potentially superior, to balloon-expandable valves (Sapien and MyVal THV series) in terms of hemodynamic performance for patients undergoing ViV TAVI for failed surgical aortic bioprostheses.
次要结局
- Incidence of Moderate/Severe Prosthesis-Patient Mismatch (PPM)(30 Days)
- Post-TAVI invasive mean aortic pressure gradient(30 Days)
- Rate of coronary artery obstruction requiring intervention(pre-discharge)
- Incidence of VARC-3 Device Success rate(30 Days)
- Freedom from Early safety composite endpoint (rate at 30 days)(30 days)
- Myocardial Infarction rate(pre-discharge and 30 days)
- Rate of moderate or severe prosthetic valve regurgitation(pre-discharge and 30 days)
- Rate of new conduction abnormalities(pre-discharge and 30 days)
- Rate of new permanent pacemaker implantation due to procedure-related conduction abnormalities(pre-discharge and 30 days)
- Echocardiographic endpoints(pre-discharge and 30 days)
- New York Heart Association (NYHA) Functional Classification(pre-procedure , 30 days)
- Quality-of-life, Kansas City Cardiomyopathy Questionnaire (KCCQ)(pre-procedure, and 30 days)
研究者
Patrick Serruys
Chief Investigator
National University of Ireland, Galway, Ireland
研究点 (1)
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