Multi-Array Ablation of the Pulmonary Veins for Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 5
- 主要终点
- Acute Safety
研究概览
简要总结
The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation. (PAF)
详细描述
This trial was a non-randomized, multi-center, prospective study of subjects with symptomatic, paroxysmal atrial fibrillation (PAF). The purpose of this study was to investigate and confirm the safety, efficacy and efficiency of the Medtronic Ablation Frontiers® Cardiac Ablation System when used for the treatment of paroxysmal AF. The trial was conducted over a 2 year period with enrollment occurring between 4 October 2007 and 1 December 2008.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of symptomatic paroxysmal atrial fibrillation defined as:
- •Self terminating AF lasting no more than 7 days
- •AF events demostrating spontaneous conversion back to sinus rhythm
- •Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year
- •AF symptoms defined as the manisfestation of any of the following: Palpitations, Fatigue, Exertional dyspnea, effort intolerance
- •Age between 18 and 70
- •Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
排除标准
- •Structural heart disease of clinical significance
- •Prior ablation for arrhythmias other than AF within the past three months
- •Prior left sided AF ablation
- •Enrollment in any other ongoing arrhythmia study protocol
- •Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
- •Active infection or sepsis
- •Any history of cerebral vascular disease including stroke or TIAs
- •Pregnancy or lactation
- •Untreatable allergy to contrast media
- •Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
- •History of blood clotting (bleeding or thrombotic) abnormalities
- •Known sensitivities to heparin or warfarin
- •Severe COPD (identified by an FEV1 < 1)
- •Severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
研究组 & 干预措施
Ablated Patients
Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.
干预措施: RF Ablation procedure (Procedure)
结局指标
主要结局
Acute Safety
时间窗: 7 days post procedure
The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site.
Chronic Safety
时间窗: 7 day post procedure to 6 months
The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.
Number of Participants With Successful Pulmonary Vein Isolation
时间窗: 6 months
Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.
Chronic Effectiveness
时间窗: 6 months
The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.
次要结局
- Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months(6 Months)
- The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline(6 months)
- Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins(After Procedure)
- Total Procedure Time(End of Procedure)
- Total Fluoroscopy Time(Post Ablation Procedure)