Diagnostic Performance of Right Ventricular Sensing Amplitude and Other Electrophysiological,Echographic, and Histological Parameters in Cardiac Amyloidosis Among Patients With Left Ventricular Hypertrophy: a Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 242
- 主要终点
- Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis
研究概览
简要总结
This multicenter prospective study aims to evaluate the diagnostic performance of right ventricular sensing amplitude measured during cardiac implantable electronic device (CIED) implantation (pacemaker or defibrillator) to identify cardiac amyloidosis in patients with left ventricular hypertrophy and conduction abnormalities.
Patients aged 65 years or older referred for CIED implantation will be included. During the procedure, electrophysiological parameters will be recorded.
Additional assessments will be performed, including cardiac scintigraphy, biological analyses, and subcutaneous adipose tissue biopsy. The results of these investigations will be used to confirm or rule out cardiac amyloidosis.
Diagnostic performance will be assessed using the area under the receiver operating characteristic curve (AUROC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient referred for CIED implantation (pacemaker or Implantable Cardioverter Defibrillator with a pacemaker feature) due to at least one conduction abnormality (Atrioventricular block, Sinoatrial block or Atrial fibrillation with slow ventricular rate). Patients referred for implantation of an Implantable Cardioverter Defibrillator with a pacemaker feature can be included if they present one of these conduction abnormalities.
- •Left ventricular hypertrophy definite as maximal end-diastolic interventricular septum thickness ≥ 12mm
- •Patients aged ≥ 65 years
- •Written consent
- •Patient affiliated to a social security
排除标准
- •Severe aortic stenosis (valve area ≤ 1 cm2)
- •Known cardiac amyloidosis
- •Indication for cardiac resynchronisation therapy
- •Indication for left bundle branch physiological pacing
- •Ejection fraction < 45% on echocardiography.
- •Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants.
- •Patient on AME (state medical aid)
- •Adults subject to a legal protection measure (guardianship, curatorship, or safeguard of justice).
- •Patients deprived of their liberty by a judicial or administrative decision.
结局指标
主要结局
Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis
时间窗: During CIED implantation
The area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude, measured during CIED implantation in patients with conduction abnormalities, for the identification of patients with cardiac amyloidosis.
次要结局
- The proportion of modifications in the treatment at the 6-month visit.(6 months after CIED implantation)
- The prevalence of cardiac amyloidosis in the study population(Up to 3 months after CIED implantation)
- Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis(During hospitalization for CEID implantation (Day 0))
- Diagnostic performance of atrial pacing thresholds for diagnostic of cardiac amyloidosis(During hospitalization for CEID implantation (Day 0))
- Diagnostic performance of ventricular pacing thresholds for diagnostic of cardiac amyloidosis(During hospitalization for CEID implantation (Day 0))
- Diagnostic performance of maximal end-diastolic interventricular septal thickness(During hospitalization for CEID implantation (Day 0))
- Diagnostic performance of adipose tissue histology(During hospitalization for CEID implantation (Day-0))
- Diagnostic performance of right atrial and ventricular sensing amplitudes and pacing thresholds(6 months after CIED implantation (Day 0))
- The implantation procedure duration (min) between patients with or without cardiac amyloidosis(During CIED implantation)
- Change in RAND 36-Item Health Survey (SF-36) score(Inclusion and 6 months after CIED implantation)
- Change in New York Heart Association (NYHA) Functional Classification(Inclusion and 6 months after CIED implantation)