Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Residual interatrial shunt
研究概览
简要总结
This is a prospective and retrospective, multicenter observational study where the study is being performed to explore on the short-term and long-term safety and efficacy of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population on a real-world basis.
详细描述
The study is both retrospective and prospective, multicenter observational study for all patient indicated for LAAO with the Amplatzer Amulet device, involving subjects who had their occluder implanted, been recently implanted or intended to undergo the procedure may be considerd to participate in the study. The sample size is 100 and is based on the estimated number of recruitments from the participating centers. The study duration is 12 months of recruitment plus 1 year follow-up for outcomes. The outcomes are measured based on the objectives of the study:
Primary objective:
To explore on the short-term and long-term (1 year) safety and efficacy of LAA occlusion with the Amplatzer Amulet Device in Southeast Asia population on a real-world basis.
Secondary objective:
To compare the practice of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population with the European registries.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •18 year of age or older
- •Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation
- •At high risk of stroke or systemic embolism defined as CHA2DS2-VASc score of more than or equal to 3
- •Deemed suitable for LAA occlusion by the treating physician, who might or might not be the investigator
- •Able to comply with the required medication regimen post-device implant
- •Able and willing to return for required follow-up visits and examinations
排除标准
- •With active endocarditis or other infections producing bacteremia
- •Where placement of the device would interfere with any intracardiac or intravascular structures
- •Reversible cause of AF (i.e. secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- •Hypersensitivity to any portion of the device material or individual components of the Amulet LAA closure device
- •Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requireemnts, or impact the scientific soundness of the clinical trial results.
研究组 & 干预措施
Patients indicated for LAAO with the Amplatzer Amulet
All subjects who are indicated for LAAO with the Amplatzer Amulet are eligible for the study.
干预措施: Amplatzer Amulet Left Atrial Appendage Occlusion Device (Device)
结局指标
主要结局
Residual interatrial shunt
时间窗: 1 year
To determine if there is residual interatrial shunt occurs after the implantation of the occluder (Yes/No). This is visualized through TOE or CT scan or TOE and CT scan.
Device embolization
时间窗: 1 year
To determine if device embolization occurs (Yes/No). This is visualized through TOE or CT scan or TOE and CT scan
Device dislocation and device related thrombus
时间窗: 1 year
To determine if there is any device-associated thrombus occurs after the implantation of the occluder (Presence/Absence). This is visualized through TOE or CT scan or TOE and CT scan.
Peri-device leak
时间窗: 1 year
To determine if there is peri-device leak occurs after the implantation of the occluder (Yes/No). This is visualized through TOE or CT scan or TOE and CT scan.
Mortality
时间窗: 1 year
To determine the mortality at 1 year after LAA occluder implantation
Ischemic Stroke and TIA
时间窗: 1 year
To determine the rate of ischemic stroke and TIA at 1 year after LAA occluder implantation
Major adverse bleeding event
时间窗: 1 year
To determine the rate of major adverse bleeding event at 1 year after LAA occluder implantation
次要结局
未报告次要终点
研究者
Dr. Keng Tat Koh
Principal Investigator / Consultant Cardiologist and Electrophysiologist
Sarawak Heart Centre