DIAMOND AF Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 84
- 试验地点
- 5
- 主要终点
- Freedom from Primary Safety Events
研究概览
简要总结
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial
详细描述
The DIAMOND AF PAS is a prospective, global, multi-center, non-randomized, single-arm observational trial. This post approval study is a condition of the Pre-Market Approval order (P200028/S002) by the U.S. Food and Drug Administration." The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the DiamondTemp™ Ablation System. To assess clinical performance and safety of the DiamondTemp™ Ablation System, study objectives will estimate primary efficacy through 36 months, and primary procedural safety at 12 months. Additionally, study objectives will characterize the ablation procedure, change in QoL through 36 months, single procedure success rate, freedom from symptomatic recurrence, and adverse events (AE) through 36 months.
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
- •A diagnosis of recurrent symptomatic paroxysmal AF
- •Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol)
- •Patient is ≥ 18 years of age
- •Planned procedure for the treatment of AF using commercially available DiamondTemp™ Ablation System
- •Patient is willing and able to provide written informed consent
- •Patient is willing and able to comply with study requirements
排除标准
- •Prior persistent AF (continuous AF that is sustained >7 days)
- •Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed.
- •Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
- •Patients with contraindications to a Holter monitor
- •Unwilling or unable to comply fully with study procedures and follow-up
结局指标
主要结局
Freedom from Primary Safety Events
时间窗: 12 months
Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
时间窗: 36 month
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation procedure using the DiamondTemp™ Ablation System.
次要结局
未报告次要终点