NCT03643224已完成不适用
A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
Medtronic Cardiac Ablation Solutions56 个研究点 分布在 6 个国家目标入组 376 人开始时间: 2018年9月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 376
- 试验地点
- 56
- 主要终点
- Primary Safety Events
研究概览
简要总结
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.
详细描述
The DIAMOND-AF II Study is a prospective, non-randomized (single-group assignment) trial being performed at multiple centers in the United States, Canada and Europe to evaluate the safety and effectiveness of the DiamondTemp Ablation System for the treatment of patients with persistent atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
- •Subjects with a history of documented symptomatic, persistent Atrial Fibrillation with 1) a physician's note documenting a continuous AF episode lasting longer than 7 days but less than 12 months AND 2) two electrocardiograms from any form of rhythm monitoring showing continuous AF taken at least 7 days apart OR a 24-hour Holter within 180 days of the ablation procedure showing continuous AF.
- •Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug.
- •Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
- •Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
- •Subject is willing and able to provide written consent.
排除标准
- •At time of enrollment and/or prior to procedure:
- •Continuous AF >12 months (long-standing persistent AF)
- •Paroxysmal AF with longest episode <7 days
- •AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
- •Rheumatic heart disease
- •Severe mitral regurgitation
- •Hypertrophic cardiomyopathy
- •LA diameter >5.5 cm
- •Left ventricular ejection fraction (LVEF) <40%
- •Currently NYHA Class III or IV or exhibits uncontrolled heart failure
- •Body Mass Index (BMI) >42 kg/m
- •LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment
- •Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation
- •Coagulopathy, bleeding diathesis or suspected procoagulant state
- •Sepsis, active systemic infection or fever (>100.5 oF / 38 oC) within a week prior to the ablation procedure
- •Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
- •Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.
- •Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
- •Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
- •Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
- •Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.
- •Life expectancy <12 months based on medical history or the medical judgement of the investigator.
- •Within 1 month of enrollment or just prior to procedure:
- •Documented LA thrombus upon imaging
- •Creatinine >2.5mg/dl or creatinine clearance <30mL/min
- •Within 3 months of enrollment:
- •Significant gastrointestinal (GI) bleed
- •Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention
- •Within 6 months of enrollment:
- •Coronary artery bypass graft (CABG) procedure
- •Implant procedure performed for ICD, CRT leads or pacemaker
- •Documented stroke, CVA, TIA or suspected neurological event
结局指标
主要结局
Primary Safety Events
时间窗: Ablation through 6 months
Participant count of a composite of safety events including: serious adverse events (SAEs), procedure and/or device-related significant pericardial effusion, severe or clinically symptomatic pulmonary vein stenosis and atrioesophageal fistula
Primary Effectiveness
时间窗: 12 months
The primary effectiveness endpoint is defined as freedom from documented AF, Atrial Flutter, (AFL) and Atrial Tachycardia (AT) episodes following the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).
次要结局
- Freedom From a Composite of Serious Adverse Events (SAEs)(Within 30-days post-index ablation)
- Freedom From Documented AF/AFL/AT Episodes(Within 3 months)
- Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy.(Within 3 months)
- Acute Procedural Success(Day of index ablation procedure)
- Single Procedure Success With Freedom From AF/AT/AFL(12 months after the index ablation procedure)
- Single Procedure Success With Freedom From All Primary Effectiveness Failures(12 months)
- AFEQT Quality of Life, Baseline(Day of index ablation procedure)
- AFEQT Quality of Life, 6-month Follow-up(6 months after index ablation procedure)
- AFEQT Quality of Life, 12-month Follow up(12 months after index ablation procedure)
- Change in AFEQT Quality of Life From Baseline to 12-month(Index ablation procedure through 12 months)
- National Institutes of Health Stroke Scale, Pre-discharge(Day of index ablation procedure)
- National Institutes of Health Stroke Scale, One- Month Follow up(One month after index ablation procedure)
- National Institutes of Health Stroke Scale, 12-month Follow-up(12 months after the index ablation procedure)
研究者
研究点 (56)
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