Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sudden Death
研究概览
简要总结
Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac biopsy or technetium pyrophosphate scintigraphy confirmed patients
- •Stage I, II, and early and late stage III in numbers as described , irrespective of EF or NYHA functional class
- •Patients aged 18 -85, both genders and of all races and ethnicities.
- •Patients must be competent to give informed consent.
- •Patients must be able to have the Biomonitor 3 implanted.
- •Amyloid stage I-III patients with existing implantable cardiac devices such as pacemakers or defibrillators
排除标准
- •Significant coronary artery disease > 75% luminal stenosis in at least 1 epicardial vessel (by cardiac catheterization or coronary computed tomography), or history of myocardial infarction or coronary revascularization.
- •Congenital heart disease.
- •Pregnant patients
- •Patients whose heart failure is felt to be secondary to primary valvular disease (>moderate/severe mitral regurgitation), uncorrected thyroid disease, obstructive or hypertrophic cardiomyopathy, pericardial disease or a systemic illness.
- •Absolute contraindications to cardiac MRI (such as renal failure with GFR<30%).
- •Unwilling or unable to provide informed consent.
- •Patients with other life threatening diseases that would likely decrease their life expectancy over the next four years.
- •Patients who are post cardiac transplant.
- •Difficulty to attend the follow-up schedule due to a history of medical noncompliance, difficulty, or unwillingness to return to the study center for follow up.
- •Evidence of ongoing bacteremia or sepsis preventing implantation of a device
- •Unwilling or able to have the Biomonitor 3 interrogated
研究组 & 干预措施
Biomonitor 3
Placement of Biotronik Biomonitor 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronik Biomonitor 3 device removed.
干预措施: Biotronik Biomonitor 3 implant of device (Device)
Biomonitor 3
Placement of Biotronik Biomonitor 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronik Biomonitor 3 device removed.
干预措施: Biotronik Biomonitor 3 explant of device (Device)
结局指标
主要结局
Sudden Death
时间窗: 6 months
Total number of patients to experience sudden death
Atrial Arrhythmias
时间窗: 6 months
Total number of participants to experience atrial arrhythmias
High Grade Atrioventricular (AV) Block
时间窗: 6 months
Total number of patients with high grade atrioventricular (AV) block.
Permanent Pacemaker Implantation
时间窗: 6 months
Total number of patients requiring permanent pacemaker implantation.
次要结局
未报告次要终点
研究者
Omar Abou Ezzeddine
Principal Investigator
Mayo Clinic