HIgh Power Short Duration Radiofrequency Ablation or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation - the HIPAF Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Recurrence of atrial arrhythmia
研究概览
简要总结
Pulmonary vein isolation (PVI) using the cryoballoon has been proven equal to RF-PVI and is widely used. High Power Short Duration Ablation in RF-PVI has been successfully tested in several trials. Prospective data comparing both strategies is lacking.
This trial will compare acute success rates, safety and foremost long-term outcome of two different PVI strategies (HPSD-PVI vs. cryo-PVI).
详细描述
In several trials and real-life data pulmonary vein isolation (PVI) using the cryoballoon technique has been proven equal to RF-PVI for the treatment of paroxysmal atrial fibrillation (PAF). Due to the "single-shot character" of the device and shorter procedure times the cryoballoon is being widely used for PVI within the last years. However, additional endpoints such as "non-excitability" of the ablation line and consecutive arrhythmias may not be targeted properly by this device also lacking a detailed contact map to evaluate potential fibrotic areas.
For the past decade, the use of RF energy for successful PVI has been the "gold standard". However, ablation time and potential gaps within the circumferential ablation line are still an issue. High power (70 Watts) over short duration (7s) (HPSD) is a recently introduced RF-PVI concept. It has been shown to be as effective as conventional RF-PVI with equal safety features, shorter procedure durations and a superior long-term outcome. Therefore, HPSD-PVI in combination with the endpoint of "non-excitability" is potentially superior with regard to freedom of atrial arrhythmia during long-term FU compared to cryo-PVI with similar procedure times.
So far, randomized prospective data comparing HPSD versus cryo-PVI are lacking.
The aim of this prospective randomized study is to compare acute success rates, safety and foremost long-term outcome of two different PVI strategies (HPSD-PVI vs. cryo-PVI):
- To find the safest and most effective treatment strategy for PAF patients. 2. To evaluate the risk of complications for both treatment strategies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic non-valvular atrial fibrillation with no prior ablation with an indication for re-ablation according to current guidelines.
- •Age 18-85 years.
- •Patient is able to provide informed consent and is willing to comply with the study protocol.
排除标准
- •Contraindications for left atrial ablation
- •History of interventional or surgical AF-ablation
- •History of stroke during the past 12 months
- •BMI >40kg/m2
- •History of mitral valve surgery
- •Severe mitral valve regurgitation
- •Inability to be treated with oral anticoagulation
- •Presence of intracardiac thrombi
- •Contraindication or absolute indication for one of the two strategies
- •Pregnancy
- •Participation in other clinical studies
- •Unwilling to follow the study protocol and to attend follow-up visits
研究组 & 干预措施
Cryo-Ablation
Cryo-Balloon (Arctic Front Advance ProTM, Medtronic, Minneapolis, MN, USA) will be advanced to the LA and navigated to the PV's using an inner-lumen circular mapping catheter (Achieve AdvanceTM, Medtronic, Minneapolis, MN, USA). After confirming complete PV sealing by the CB using occlusion angiograms cryothermal energy will be applied for min 120 seconds aiming at PV isolation of all PV's according to the clinical standard.
干预措施: Ablation (Procedure)
High Power Short Duration-Ablation
A detailed electroanatomical map of the left atrium during sinus rhythm will be acquired using Ensite (Abbott, St. Paul, MN, USA).
Upon completion of the LA map, a second transseptal puncture will be performed in order to insert an ablation catheter. To achieve antral PVI irrigated radiofrequency current ablation will be performed using a power of 70W and a flush rate of 8-30ml/min with a duration of 5 seconds for the anterior and 7 seconds for the posterior LA. Ablation catheters used will contain Flexibilty (Abbott, St. Paul, MN, USA) and TactiFlex (Abbott, St. Paul, MN, USA).
干预措施: Ablation (Procedure)
结局指标
主要结局
Recurrence of atrial arrhythmia
时间窗: 12 months after a 3 months blanking period
Combined primary endpoint of recurrent atrial arrhythmia, onset of new AAD or re- ablation of atrial arrhythmia during the follow-up of 12 months after a 3-months blanking period.
次要结局
- Cardioversions(12 months after a 3 months blanking period)
- Procedural data(During the procedure)
- Periprocedural complications(Within 48 hours of procedure)
- Number of re-hospitalisations(12 months after a 3 months blanking period)