Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 310
- 试验地点
- 7
- 主要终点
- Changes in Quality of life (Efficacy)
研究概览
简要总结
Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,
详细描述
This is a prospective, multicenter, randomized, single-blinded design trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a stented surgical bioprosthesis with a labeled size ≤25 mm. Following the Heart Team's decision to proceed with a ViV-TAVR procedure with the SAPIEN 3 ULTRA valve (or its subsequent iterations), patients will be randomized to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.
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
- Single (Participant)
盲法说明
Single-blinded trial
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
- •Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team
- •Surgical stented bioprosthetic valve (label size ≤25 mm)
- •TAVR with the SAPIEN 3 Ultra valve
排除标准
- •Stentless or sutureless surgical valves
- •Trifecta bioprosthesis
- •Hancock II bioprosthesis
- •High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT <4 mm or based on the criterion of the heart team responsible for the procedure).
- •Impossibility to obtain written informed consent
结局指标
主要结局
Changes in Quality of life (Efficacy)
时间窗: 12 months follow-up
Change in quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ). All score are represented on a 0-to-100-point scale (lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life).The KCCQ is a 7 domains questionnaire; symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy.
Periprocedural complications (Safety)
时间窗: Periprocedural
Periprocedural complications including in-hospital mortality, stroke, annular rupture, coronary obstruction, new-onset left bundle branch block, need for permanent pacemaker implantation and conversion to open heart surgery.
次要结局
- Exercise capacity(1 month and 12 months follow-up)
- Clinical safety endpoints(1 and 12 months follow-up and yearly up to 5 years)
- re-hospitalization(1 and 12 months follow-up and yearly up to 5 years)
- Heart failure(1 and 12 months follow-up and yearly up to 5 years)
- Changes in Quality of life(after 1-year follow-up (yearly up to 5 years))
- Changes in Left ventricle mass(1-month and 1-year follow-up)
- Residual transvalvular gradient(1 month and 12 months follow-up)
- Combined enpoint: Moderate or severe prothesis-patient mismatch and/or moderate or severe aortic regurgitation (valve performance)(1 month and 12 months follow-up)
- wear and tear deterioration (Structural valve degeneration)(1 and 12 months follow-up and yearly up to 5 years)
- flail leaflet (Structural valve degeneration)(1 and 12 months follow-up and yearly up to 5 years)
- leaflet fibrosis and/or calcification (Structural valve degeneration)(1 and 12 months follow-up and yearly up to 5 years)
- Leaflet disruption (Structural valve degeneration)(1 and 12 months follow-up and yearly up to 5 years)
- strut fracture or deformation (Structural valve degeneration)(1 and 12 months follow-up and yearly up to 5 years)
- Valve re-intervention(1 and 12 months follow-up and yearly up to 5 years)
研究者
Josep Rodes-Cabau
Principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval