2024-514587-44-00招募中2 期
Impact of local tissue inflammation on intramyocardial conduction pathways post percutaneous valve : evaluation by positron emission tomography on exploratory cohort
Centre Hospitalier Regional Et Universitaire De Brest1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intra-hospital "occurrence of a conductive disorder", a composite criterion comprising: 1) complete AVB, 2) high-grade AVB, 3) LBB, 4) RBB, 5) AVB1; assessed by electrocardiograms (ECG post percutaneous valve implantation) performed during the initial hospitalization
研究概览
简要总结
To study the association between the occurrence of conduction disorders after percutaneous aortic valve and the degree of inflammation of intramyocardial conduction pathways assessed by 18F-FDG PET-CT, based on observation of subjects in an exploratory cohort.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Patient with tight aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR maximum transvalvular velocity ≥ 4 m/s OR mean transvalvular gradient ≥ 40 mmHg, assessed by transthoracic echocardiography (TTE) performed in a patient at rest
- •Symptomatic patient with: dyspnea ≥ stage 2 according to New York Heart Association (NYHA) classification OR pathological stress test with onset of symptoms on exertion, drop in blood pressure or rhythm disturbance on exertion OR Asymptomatic with Left Ventricular Ejection Fraction (LVEF) < 50%
- •Patient with vascular anatomy compatible with percutaneous femoral valve implantation
- •Patient affiliated to or benefiting from a health insurance scheme
- •Patient has provided free, informed and written consent
排除标准
- •Patients with pacemakers or triple-chamber defibrillators prior to TAVI (Transcatheter Aortic Valve Implantation) implantation
- •Patient deprived of liberty by judicial or administrative decision, under guardianship or trusteeship
- •Patient with life expectancy < 12 months
- •Patients with a uni or bicuspid aortic valve
- •Patients with severe left ventricular dysfunction (LVEF < 30%)
- •Patients with other significant valvulopathies: aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis
- •Patient with iliofemoral vascular anatomy preventing safe passage of valve
- •Patient with pre-existing TAVI bioprosthesis or mechanical prosthesis, in any position
- •Inability or refusal to give consent
- •Pregnant or breast-feeding woman
- •Patients under court protection or family guardianship
结局指标
主要结局
Intra-hospital "occurrence of a conductive disorder", a composite criterion comprising: 1) complete AVB, 2) high-grade AVB, 3) LBB, 4) RBB, 5) AVB1; assessed by electrocardiograms (ECG post percutaneous valve implantation) performed during the initial hospitalization
Intra-hospital "occurrence of a conductive disorder", a composite criterion comprising: 1) complete AVB, 2) high-grade AVB, 3) LBB, 4) RBB, 5) AVB1; assessed by electrocardiograms (ECG post percutaneous valve implantation) performed during the initial hospitalization
次要结局
- Post-TAVI pacemaker dependence at 1 month, 6 months
- "Occurrence of a conductive disorder" within 6 months of discharge from TAVI hospitalization
- Post-TAVI pacemaker implantation
研究者
Pr Romain DIDIER
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
研究点 (1)
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