AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 15
- 主要终点
- Technical success
研究概览
简要总结
The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in subjects with nonvalvular atrial fibrillation and assess adverse events up to two (2) or more years post implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (documentation may include an electrocardiogram (ECG), Holter, or event recorder)
- •Subject must be ≥18 years of age
排除标准
- •Subject with an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device
- •Subject who has a history of surgical ASD or PFO repair
- •Subject with a history of stroke and unrepaired PFO
- •Subject who has moderate to severe aortic or mitral valve stenosis or regurgitation as assessed by the investigator
- •Subject who has a mitral or aortic prosthetic valve
- •Subject who has a planned ablation procedure for atrial fibrillation 30 days after the ACP implant
- •Subject with New York Heart Association (NYHA) grade 4
- •Subject with evidence of pericardial effusion at baseline evaluation
- •Subject who has complex atheroma with mobile plaque of the descending aorta and/or aortic arch
- •Subject who has an intracardiac thrombus
- •Subject who has carotid disease as assessed by the investigator, requiring treatment, which includes revascularization and/or medical treatment
- •Subject with active infection or active endocarditis
- •Subject who has an acute or recent myocardial infarction (MI) or unstable angina (recent is defined as within 6 months of implant date)
- •Subject who has had recent major cardiac surgical procedure (recent is defined as within 6 months of implant date)
- •Subject with malignancy or other illness where life expectancy is less than one year
- •Subject who is pregnant, breastfeeding, or desires to become pregnant during their first six months of follow-up
- •Subject or legally authorized representative who is unable to provide informed consent
- •Subject who will not be able to be followed for the duration of the clinical study
- •Subject with any medical disorder or severe disability that would interfere with completion or evaluation of clinical study results (for e.g. uncontrolled hypertension, uncontrolled diabetes, renal failure, in situ inferior vena cava (IVC) filter)
结局指标
主要结局
Technical success
时间窗: At implant
Defined as delivery and release of the ACP device, including recapture and/or replacement, as necessary. This success will be calculated among subjects in whom the device enters the body
The rate of occurrence for any reported adverse event experienced by subjects enrolled.
时间窗: Through 2 years
Closure
时间窗: 6 months
Defined as absence of flow or flow of ≤3mm jet into the LAA at procedure and at six (6) months as assessed by Transoesophageal Echocardiography (TOE).
次要结局
未报告次要终点