Cryoballoon Ablation Without Use of Contrast Dye for the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Isolation of a pulmonary vein without the use of contrast and within the scheduled timeframe
研究概览
简要总结
Pulmonary vein isolation using cryoballoon ablation is well established method for the treatment of atrial fibrillation. As a rule, cryoenergy delivery is preceded by documenting the full vein occlusion. It is assessed by venography, performed by injecting contrast through the inner lumen of the balloon catheter after the vein is blocked with a balloon. Achieving full vein occlusion in certain situations can be challenging and may require multiple attempts, which may expose the patient to increased doses of contrast and radiation.. At the same time, the purpose of ablation is an electrical isolation of pulmonary veins.
Experts postulate ablation in the antrum and the so-called "proximal-seal technique", which in some cases may require to start cryoapplication before the vein is fully sealed. This approach minimizes the risk of the pulmonary vein stenosis, damage to structures immediately adjacent to the atrium and phrenic nerve palsy. In addition, in many cases the displacement of the balloon after several dozen seconds of cryoapplication, usually by pulling it, causes full sealing of the vein, contributes to further lowering the temperature and leads to full electrical isolation of the vein, which is the aims of ablation.
All the above-mentioned facts indicate that demonstrating full vein occlusion using angiography before the initiation of cryoenergy application is of limited value. Moreover, there are a number of parameters related to cryoballoon ablation that indicate acute and long term vein isolation.
Taking into account the arguments presented above, it seems that it is possible to perform an effective and safe isolation of the pulmonary veins using the cryoballoon ablation technique without confirmation by venography that PV is occluded. Along with dissemination of the method, such attempts are and will be made by some operators. Therefore, a systematic approach to this issue is important. It should define the conditions that should be met in order for the procedure in the proposed modification to be implemented effectively and safely. In addition, a protocol of ablation for this modification is required.
详细描述
Pulmonary vein isolation using cryoballoon ablation is well established method for the treatment of atrial fibrillation. As a rule, cryoenergy delivery is preceded by documenting the full vein occlusion. It is assessed by venography, performed by injecting contrast through the inner lumen of the balloon catheter after the vein is blocked with a balloon. Achieving full vein occlusion in certain situations can be challenging and may require multiple attempts, which may expose the patient to increased doses of contrast and radiation.. At the same time, the purpose of ablation is an electrical isolation of pulmonary veins.
Experts postulate ablation in the antrum and the so-called "proximal-seal technique", which in some cases may require to start cryoapplication before the vein is fully sealed. This approach minimizes the risk of the pulmonary vein stenosis, damage to structures immediately adjacent to the atrium and phrenic nerve palsy. In addition, in many cases the displacement of the balloon after several dozen seconds of cryoapplication, usually by pulling it, causes full sealing of the vein, contributes to further lowering the temperature and leads to full electrical isolation of the vein, which is the aims of ablation.
All the above-mentioned facts indicate that demonstrating full vein occlusion using angiography before the initiation of cryoenergy application is of limited value. Moreover, there are a number of parameters related to cryoballoon ablation that indicate acute and long term vein isolation.
Taking into account the arguments presented above, it seems that it is possible to perform an effective and safe isolation of the pulmonary veins using the cryoballoon ablation technique without confirmation by venography that PV is occluded. Along with dissemination of the method, such attempts are and will be made by some operators. Therefore, a systematic approach to this issue is important. It should define the conditions that should be met in order for the procedure in the proposed modification to be implemented effectively and safely. In addition, a protocol of ablation for this modification is required.
Course of ablation. All ablations will be performed using Medtronic Arctic Front Advance catheter system as well as future generations of Medtronic cryoballoon catheter systems.
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
- •Patients with paroxysmal AF - episodes lasting up to 7 days or cardioverted before this time
- •At least 4 AF attacks in the last 12 months
- •Informed consent for participation in the study
- •Age > 18 and < 70 years
- •Left atrium diameter (PLAX) < 4,5 cm and left atrial area < = 30 cm2
- •Left ventricle ejection fraction > 45%
- •Four separate veins visualised in computed tomography prior to the ablation
排除标准
- •Withdrawal of consent for the procedure
- •Documented typical atrial flutter prior to the ablation
- •Thrombus in left atrium
- •GFR < 60 ml/min
- •Pregnancy
- •Common trunk of left or right pulmonary veins documented on computed tomography (preferred) or by means of other imaging methods
- •Other conditions that preclude AF ablation including: infection, uncontrolled hyperthyroidism, significant anaemia and thrombocytopenia, acute cardiac / internist / surgical conditions
结局指标
主要结局
Isolation of a pulmonary vein without the use of contrast and within the scheduled timeframe
时间窗: Through study completion, an average of 2 years
Acute result will be assessed. Vein isolation assessment will be done using a diagnostic circular catheter (Achieve, Medtronic), by demonstrating entrance and exit block
次要结局
- Percentage of patients with stable sinus rhythm, without atrial fibrillation episodes during follow-up(During one year follow-up)
- X-ray time exposure(Through study completion, an average of 2 years)
- Percentage of patients in whom isolation of all pulmonary veins will be achieved without the use of contrast(Through study completion, an average of 2 years)
- Left atrial dwelling time(Through study completion, an average of 2 years)
- Radiation dose(Through study completion, an average of 2 years)
- Number of complications assessed(Through study completion, an average of 2 years)
- The amount of contrast dye used(Through study completion, an average of 2 years)
研究者
Pawel Derejko
Head of Cardiology Department
Medicover Hospital