Detection of Cardiac Amyloidosis Using Right Ventricular Sensing Amplitude in Patients With Left Ventricular Hypertrophy (DETECT-AMY)
2026年7月27日 更新者：Assistance Publique - Hôpitaux de Paris
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
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).
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
242
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Samia BALOUL
- 电话号码：0149 81 33 85
- 邮箱：samia.baloul@aphp.fr
研究联系人备份
- 姓名：Philippe Le Corvoisier, MD, PhD
- 电话号码：01 49 81 37 96
- 邮箱：philippe.lecorvoisier@aphp.fr
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Diagnostic Assessment During CIED Implantation
Single Group
|
Procedure of CIED implantation will not be modified by inclusion in the study. However, several exams will be performed to confirm or ruled out the diagnosis of cardiac amyloidosis: During the procedure: Subcutaneous adipose tissue sampling Collection of a subcutaneous adipose tissue sample during device implantation for histological analysis to detect amyloid deposits. Blood sampling for serum free light chain assay, serum and urine electrophoresis with immunofixation (baseline visit) Diagnostic Test: 99mTc-DPD or HMDP Scintigraphy Cardiac scintigraphy performed within 3 months after implantation to assess myocardial tracer uptake and detect cardiac amyloidosis. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis
大体时间：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.
|
During CIED implantation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis
大体时间：During hospitalization for CEID implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day 0)
|
|
Diagnostic performance of atrial pacing thresholds for diagnostic of cardiac amyloidosis
大体时间：During hospitalization for CEID implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day 0)
|
|
Diagnostic performance of ventricular pacing thresholds for diagnostic of cardiac amyloidosis
大体时间：During hospitalization for CEID implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day 0)
|
|
Diagnostic performance of maximal end-diastolic interventricular septal thickness
大体时间：During hospitalization for CEID implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of maximal end-diastolic interventricular septum thickness at echocardiography for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day 0)
|
|
Diagnostic performance of adipose tissue histology
大体时间：During hospitalization for CEID implantation (Day-0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of histological analysis of adipose tissue for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day-0)
|
|
Diagnostic performance of right atrial and ventricular sensing amplitudes and pacing thresholds
大体时间：6 months after CIED implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of 12-lead electrocardiogram data (low voltage in limb leads) for identifying patients with cardiac amyloidosis.
|
6 months after CIED implantation (Day 0)
|
|
The implantation procedure duration (min) between patients with or without cardiac amyloidosis
大体时间：During CIED implantation
|
During CIED implantation
|
|
|
The prevalence of cardiac amyloidosis in the study population
大体时间：Up to 3 months after CIED implantation
|
Up to 3 months after CIED implantation
|
|
|
The proportion of modifications in the treatment at the 6-month visit.
大体时间：6 months after CIED implantation
|
6 months after CIED implantation
|
|
|
Change in RAND 36-Item Health Survey (SF-36) score
大体时间：Inclusion and 6 months after CIED implantation
|
Change in health-related quality of life between inclusion and the 6-month visit, assessed using the RAND 36-Item Health Survey, Version 1.0 (SF-36).
The questionnaire comprises 36 items grouped into 8 domains.
Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
|
Inclusion and 6 months after CIED implantation
|
|
Change in New York Heart Association (NYHA) Functional Classification
大体时间：Inclusion and 6 months after CIED implantation
|
Change in New York Heart Association (NYHA) Functional Classification between baseline and the 6-month visit in patients with and without cardiac amyloidosis.
The NYHA Functional Classification ranges from Class I to Class IV, with higher class indicating worse functional status.
|
Inclusion and 6 months after CIED implantation
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Philippe Le Corvoisier, MD, PhD、Assistance public Hôpitaux de Paris
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2029年12月1日
研究完成 (估计的)
2030年5月5日
研究注册日期
首次提交
2026年7月10日
首先提交符合 QC 标准的
2026年7月27日
首次发布 (实际的)
2026年7月29日
研究记录更新
最后更新发布 (实际的)
2026年7月29日
上次提交的符合 QC 标准的更新
2026年7月27日
最后验证
2026年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- APHP240915
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不
研究美国 FDA 监管的设备产品
不
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