Ablation of the Pulmonary Veins for Paroxysmal Afib (MAP-PAF)
2018年9月17日 更新者：Medtronic Cardiac Rhythm and Heart Failure
Multi-Array Ablation of the Pulmonary Veins for Paroxysmal Atrial Fibrillation
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)
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
55
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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.)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Successful Pulmonary Vein Isolation
大体时间：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.
|
6 months
|
|
Chronic Effectiveness
大体时间：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.
|
6 months
|
|
Acute Safety
大体时间：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.
|
7 days post procedure
|
|
Chronic Safety
大体时间：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.
|
7 day post procedure to 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months
大体时间：6 Months
|
Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study.
Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise.
Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe).
Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic).
|
6 Months
|
|
The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline
大体时间：6 months
|
The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures.
In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit.
The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest).
The subscales are averaged together for a total score between 0 to 100.
A higher score represents a better outcome when compared to a lower score.
|
6 months
|
|
Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins
大体时间：After Procedure
|
Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation
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After Procedure
|
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Total Procedure Time
大体时间：End of Procedure
|
Measurement of total procedure time defined as "skin to skin" and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)
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End of Procedure
|
|
Total Fluoroscopy Time
大体时间：Post Ablation Procedure
|
Total time that flouroscopy was used during the ablation procedure.
|
Post Ablation Procedure
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年10月1日
初级完成 (实际的)
2009年9月1日
研究完成 (实际的)
2011年7月1日
研究注册日期
首次提交
2008年8月28日
首先提交符合 QC 标准的
2008年8月29日
首次发布 (估计)
2008年9月1日
研究记录更新
最后更新发布 (实际的)
2018年9月19日
上次提交的符合 QC 标准的更新
2018年9月17日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.