The MAGiC™ Ablation Catheter in Congenital Heart Disease Arrhythmias Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Stereotaxis
- 入组人数
- 40
- 主要终点
- Acute Success
研究概览
简要总结
The goal of this observational study is to collect real world performance and to confirm the effectiveness and safety of the MAGiC Ablation Catheter for the treatment of supraventricular tachycardia in adult patients with congenital heart disease:
To estimate the rate of acute procedural success and to estimate the rate of chronic success through 6 months post procrdure.
Participants will be asked to have a cardiac ablation procedure and visit their doctor at 1 week, 1 month and 6 monhs post procedure.
详细描述
The MAGiC-CHD Post-Approval Study is a prospective, non-randomized, multi-center, single-arm study to confirm the effectiveness and safety of the MAGiC Ablation Catheter for the treatment of supraventricular tachycardia (SVT) in adult patients with congenital heart disease (CHD) and limited vascular access or difficult access to the target cardiac chamber.
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
- •Adult (aged 18 or older at time of consent).
- •Clinically indicated for catheter ablation of a supraventricular tachycardia (macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia)
- •History of congenital heart disease with anatomic abnormalities and/or previous surgical interventions and/or previous surgical interventions that limit vascular or target chamber access by conventional manual catheter navigation.
- •Willing and capable of attending scheduled follow up visits for the study duration = Willing and able to provide informed consent.
排除标准
- •Atrial fibrillation is the target arrhythmia for the catheter ablation.
- •Unable to be safely exposed to the level of magnetic fields used for Robotic Magnetic Navigation
- •A history of sensitivity to foreign objects (gold, platinum/iridium, Pebax materials) or extreme allergies.
- •Acute illness or active systemic infection.
- •Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection.
- •Hemodynamic instability (to an extent that would make an interventional procedure high risk).
- •Presence of intracardiac thrombus.
- •Where MAGiC would need to cross a prosthetic valve.
- •Where MAGiC would need to be used in the coronary arteries.
- •Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation.
- •Acute myocardial infarct (within the previous 30 days).
- •Unstable angina at the time of enrollment.
- •History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days.
- •Previous cardiac ablation within the last 30 days.
- •Inaccessible for follow-up visits for 6 months post ablation.
- •Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study.
- •Any reason or condition that, in the judgement of the investigator, makes the subject ineligible for the investigation.
研究组 & 干预措施
MAGiC CHD
A patient requiring a cardiac ablation for SVT with CHD
干预措施: Cardiac ablation using the MAGiC Ablation Catheter (Device)
结局指标
主要结局
Acute Success
时间窗: Peri-procedural
Non-indcability of Supraventricular Tachycardia (SVT)
Chronic Success
时间窗: 6 months
subjects free from the treated index arrhythmia through 6 months post procedure. To be counted as recurrence, the recurrent arrhythmia must be the same arrhythmia as primary index arrhythmia and must last at least 30 seconds on Holter monitor or event monitor recording, OR present on the entirety of a 12-lead ECG (minimum recording duration of 10 seconds) OR documented on a personal ECG device recording of a minimum of 30 seconds duration.
Acute Safety - Device or peocedure related adverse events
时间窗: 7 days post procedure
Device or procedure related serioius adverse events which occurred prior to 7 days post-procedure
次要结局
- Serious device related events(6 months)
- Acute & Chronic Success(6 months)
- Procedure time(Peri-procedural)
- Fluoroscopy Duration(Peri-procedural)
- Hospitlization(6 months)
- Serious Advere Events(6 months)
- Quality of Life and arrhythmia burden(6 months)
- Unmet medical need(Peri-procedural)
- Fluoroscopy Dose(Peri-procedural)