Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure: A One-Year Single Centre Experience in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of Residual Shunt from post-procedure to 6 hours, 24 hours and 48 hours
研究概览
简要总结
Since the first successful percutaneous closure under transoesophageal echocardiographic (TEE) guidance, many centres explored transcatheter procedures without fluoroscopy. This single centre study aims to show the feasibility and safety of percutaneous patent ductus arteriosus (PDA) closure under echocardiography-only guidance during our one-year experience. Patients with PDA were recruited for percutaneous PDA closure guided by either fluoroscopy or echocardiography-only in National Cardiovascular Center Harapan Kita. Patients were evaluated clinically and radiologically using TTE at 6, 24 and 48 hours after the procedure. Primary endpoint was the procedural success. Secondary endpoints were the procedural time and the rate of adverse events. Echocardiography-guided PDA closure is non-inferior to fluoroscopy-guided PDA closure, with similar procedural times. However, this method is operator-dependent and requires an experienced team for it to be performed successfully.
详细描述
From March 2019 to April 2020, a total of 60 patients with PDA were recruited as participants for this prospective, single-centre, non-randomized clinical trial. They were divided equally into two groups: the fluoroscopy group who underwent percutaneous PDA guided by fluoroscopy and the echocardiography group who underwent percutaneous PDA closures guided by transthoracic echocardiography (TTE) and TEE at the National Cardiovascular Centre Harapan Kita, Jakarta, Indonesia. Patients with stable hemodynamic and clinically asymptomatic PDA were evaluated and considered for transcatheter PDA closure. Significant chamber enlargement and mild to moderate pulmonary hypertension were also indications for transcatheter closure. Ductal morphology was evaluated using multiplanar TTE and TEE imaging.
After the procedures, patients were evaluated and followed-up after 6, 24 and 48 hours to observe any residual shunts and complications. This study protocol conforms to the ethical guidelines of the Declaration of Helsinki and the Nuremberg Code with approval from the Research Ethics Committee of National Cardiovascular Center Harapan Kita No LB.02.01/VII/475/KEP076/2020. Written consent to perform the procedure and to use the patients' medical records for this study was obtained from the patients or their parents.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PDA, age <= 18yo
排除标准
- •>= 18yo, Eisenmenger syndrome, coexistence of other associated congenital heart disease
结局指标
主要结局
Change of Residual Shunt from post-procedure to 6 hours, 24 hours and 48 hours
时间窗: 6, 24 hours, and 48 hours
PDA residual shunt post PDA closure
Change of Device Position from post-procedure to 6 hours, 24 hours and 48 hours
时间窗: 6, 24 hours, and 48 hours
If device dislodge during follow-up
次要结局
- Complication(6, 24hours, and 48hours)
- Procedural time(6hours)
研究者
Sisca Natalia Siagian
Principal Investigator
National Cardiovascular Center Harapan Kita Hospital Indonesia