Magnetocardiography in Long QT Syndrome: A Prospective Study of Its Clinical and Prognostic Utility
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of successful dofetilide loading using Magnetocardiography
研究概览
简要总结
The primary objective of this observational study is to evaluate whether magnetocardiography (MCG) findings more accurately predict clinical outcomes in patients with acquired Long QT syndrome compared to ECG. The secondary objective is to assess differences in QT interval length between MCG and ECG. The primary safety objective is to characterize the safety profile of the CardiAQ MCG device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years on the date of consent
- •Ability for participant to comply with study requirements
- •Written informed consent
- •Confirmed diagnosis of atrial fibrillation and receiving dofetilide for rhythm control in the inpatient setting.
排除标准
- •Pregnant or breastfeeding
- •Active thoracic metal implants (including pacemaker, insertable cardiac monitor, or internal defibrillators).
- •External electrical pads or devices (e.g. Pacer pads, ECG electrodes, heart rate patch), that must remain on patient's chest during MCG scan
- •Inability to lie down in a supine/inclined position and stay still on the examination bed
- •Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol
研究组 & 干预措施
Subjects diagnosed with atrial fibrillation
干预措施: Magnetocardiography (Diagnostic Test)
结局指标
主要结局
Number of successful dofetilide loading using Magnetocardiography
时间窗: Baseline
Dofetilide loading is considered successful if the following conditions are met: 1. No excessive QTc prolongation QTc remains \<500 ms, and no \>15% increase from baseline. 2. No sustained VT or recurrent/symptomatic non-sustained VT (NSVT) suggestive of proarrhythmia. 3. No symptomatic bradycardia or hemodynamic instability 4. Stable renal function 5. No deterioration necessitating dose reduction or discontinuation. 6. Discharge on a stable dose
Number of successful dofetilide loading using Electrocardiogram
时间窗: Baseline
Dofetilide loading is considered successful if the following conditions are met: 1. No excessive QTc prolongation QTc remains \<500 ms, and no \>15% increase from baseline. 2. No sustained VT or recurrent/symptomatic non-sustained VT (NSVT) suggestive of proarrhythmia. 3. No symptomatic bradycardia or hemodynamic instability 4. Stable renal function 5. No deterioration necessitating dose reduction or discontinuation. 6. Discharge on a stable dose
次要结局
- Magnetocardiography - QT interval length(Baseline)
- Electrocardiogram - QT interval length(Baseline)
研究者
Mohamad Adnan Alkhouli
Principal Investigator
Mayo Clinic