A Randomized Trial to Investigate the Significance of Complete Versus Incomplete Electrical Isolation of Pulmonary Veins by Radiofrequency-induced Linear Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 6
- 主要终点
- - Time to first recurrence of symptomatic AF with duration of more than 30 sec on trans-telephonic ECG monitoring or detection of asymptomatic AF defined as 2 consecutive recordings of AF during a minimum of 72 hours
研究概览
简要总结
The purpose of this study is to investigate the significance of complete versus incomplete electrical isolation of pulmonary veins by radiofrequency-induced linear lesions in patients with paroxysmal atrial fibrillation.
The study hypothesis ist that the complete linear PV isolation ablation is superior to the non-complete linear PV isolation on the outcome of patients with idiopathic drug-refractory atrial fibrillation. As a second hypothesis in this adaptive study design, the non-inferiority of the complete linear PV isolation strategy will be tested.
详细描述
Atrial fibrillation can be cured by elimination of triggering events such as atrial extrasystoles originating from the pulmonary veins (PV) by selective or linear radiofrequency current applications.
Although electrical isolation can be demonstrated by a circumferential mapping catheter positioned at the PV ostium, longterm effect of such EP-guided PV isolation procedures achieve about 60-70% of stable sinus rhythm during follow-up even in experienced centers. Re-investigation of symptomatic patients after initially electrically isolated PVs demonstrated a substantial amount of PV reconduction which might explain the arrhythmia recurrence.
Although it was demonstrated that linear lesions for PV isolation is superior to the selective ablation approach, conflicting data exists on the necessity to achieve complete linear lesions. The groups of Pappone et al and Oral et al both published a success rate of more than 90% of patients in sinusrhythm irrespective of the line completeness, which both groups estimated to be reached in only 30% of cases.
Several advantages and disadvantages could advocate for either the complete versus the incomplete ablation strategy: Performing the complete EP-guided linear PV isolation strategy might take longer (mean duration 4.5 hours vs about 2 hours) and could thereby potentially result in a higher risk of procedure-associated complications (air embolism, thrombus formation, perforation). In addition, three transseptal sheaths might increase the risk of tamponade and might aggravate the ability to safely navigate catheters in the left atrium. Certainly, the procedure costs are higher, since in addition to the 3D mapping system two circular mapping catheters are mandatory to facilitate the lesion deployment and avoidance of intra-PV ablation.
In addition, an ablation strategy that does not depend on complete line deployment may be sufficient to achieve stable sinus rhythm. Although, additional linear lesions between the PV isolation segments and towards the mitral annulus as proposed by several centers with incomplete linear PV isolation approaches might not be necessary to achieve stable sinus rhythm. Potential complications such as atrio-esophageal fistula formation could be avoided if no additional lesions eg. along the LA roof would be necessary. Both the costs of the additional material (transseptal sheaths, circular mapping catheters) and the shorter procedure duration (about 2 hours) would be reduced. On the other hand, these costs would be balanced by the reduced number of re-ablation, if incomplete PV isolation would indeed lead to a higher AF recurrence rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic paroxysmal symptomatic atrial fibrillation refractory to antiarrhythmic therapy
- •Age 50 - 85 years
- •Patient willing to participate in randomized trial and an invasive follow-up at month 3 (-6)
- •Structural normal heart
- •Patient willing and able to participate in 12 months follow-up period
- •ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) for at least one AF event in the prior year (related to symptomatic or asymptomatic episodes) with an average number of one episode per month
- •Written informed consent of the patient
排除标准
- •Patients who have had previous pulmonary vein ablation procedures Patients with atrial fibrillation secondary to a reversible cause
- •Known presence of intracardiac or other thrombi
- •Evidence of obstructive lung disease requiring bronchodilator therapy
- •Pregnant females or those of child bearing potential who have not had a negative pregnancy test within 48 hours before treatment.
- •Other medical illness (i.e. cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)
- •History of bleeding diathesis or suspected pro-coagulant state contraindication to anticoagulation therapy
- •Hyperthyroidism or hypothyroidism manifested clinically and in laboratory tests (TSH, T3, T4)
- •Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted.
- •Drug addiction or chronic alcohol abuse
- •Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
- •Evidence of an uncooperative attitude
结局指标
主要结局
- Time to first recurrence of symptomatic AF with duration of more than 30 sec on trans-telephonic ECG monitoring or detection of asymptomatic AF defined as 2 consecutive recordings of AF during a minimum of 72 hours
Time to first recurrence of symptomatic AF with duration of more than 30 sec on trans-telephonic ECG monitoring or detection of asymptomatic AF defined as 2 consecutive recordings of AF during a minimum of 72 hours
次要结局
- - Number and total duration of documented AF episodes
- - Number of visits without hospitalization
- - Quality of life
- - Number of "serious adverse events of special interest"
- - Time to first occurrence of any documented relapse of atrial fibrillation
- - Number of hospitalizations due to atrial fibrillation
- - Procedure parameters (duration, fluoroscopy, number of radiofrequency applications)
- - Procedural costs (including the costs of re-ablation if AF recurrence occurs)
