Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis in At-Risk Population: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Cardiac biopsy results
研究概览
简要总结
People eligible for this study have had the suggestion from their doctor to receive a cardiac pacemaker or defibrillator to treat a cardiac condition as part of their routine care. We are doing this study to understand if obtaining a tissue sample from their body during a device implant may assist in the early diagnosis of Transthyretin Cardiac Amyloidosis (ATTR-CM).
详细描述
The aim of our study is to assess the feasibility of using chest wall fat-pad biopsy and endomyocardial biopsy in early diagnosis of ATTR-CM in at-risk patients undergoing permanent pacemaker implantations.
Specific Objectives:
- To assess the incidence of ATTR-CM in at-risk patients undergoing permanent pacemaker implantation
- To develop a workflow for the diagnosis of ATTR-CM in pacemaker-indicated patients
- To assess the utility of chest wall fat pad biopsy from the pacemaker pocket in the diagnosis of amyloidosis
- To assess the utility of endomyocardial biopsy at the time of pacemaker implant in the diagnosis of ATTR-CM in an at-risk population
The study team will enroll 70 patients who satisfy inclusion and exclusion criteria. The study team will assess the incidence of amyloidosis and the utility of chest wall fat-pad biopsy, endomyocardial biopsy and deep septal biopsy in the diagnosis of amyloidosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥65(or 50-64 with hereditary-ATTR risk: family history of ATTR or known TTR variant)
- •Patients with an indication for permanent pacemaker or CRT or ICD device
- •Patients willing to comply with all study procedures and be available for the duration of the study. And any one of the following:
- •Diagnosis of atrial fibrillation or sinus node dysfunction Diagnosis of AV block Heart failure with preserved ejection fraction Heart failure with reduced ejection fraction Evidence for infiltrative cardiomyopathy Unexplained renal insufficiency Peripheral neuropathy Family h/o cardiomyopathy Family h/o peripheral neuropathy Carpal tunnel syndrome, unprovoked tendon rupture Hip or knee arthroplasty Unexplained RV or LV wall thickening on echocardiogram Unexplained, persistent low-level elevation of cardiac troponins Unexplained orthostatic hypotension Discordance between QRS voltage on ECG and wall thickness on echo Black race Spinal stenosis IVS thickness ≥ 1.2cm (by TTE or cardiac MRI)
排除标准
- •Inability to provide informed consent
- •Enrolled in a concurrent study that may confound the results of this study
结局指标
主要结局
Cardiac biopsy results
时间窗: From enrollment to the end of treatment at 15-21 months.
* ATTR-CM positive results of fat-pad biopsy, endomyocardial biopsy, and deep septal biopsy * Overall percentage of positive results in this high-risk population
次要结局
- Safety Events(From enrollment to the end of treatment at 15-21 months)