Improving Esophageal Protection During AF Ablation: a Multicenter Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 12
- 主要终点
- Freedom from the treated atrial arrhythmia
研究概览
简要总结
Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the esophagus caused by thermal energy being transmitted to the esophagus from the heart. The esophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe esophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result.
In recent studies, it was shown that a more advanced type of esophageal probe (ensoETM) that cools the esophagus during ablation is better at protecting the esophagus from ablation-related injury compared to the standard care temperature monitoring probe currently used. The ensoETM is a CE marked and FDA-cleared device, with an intended purpose of controlling patient temperature and has received marketing authorization from FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
The purpose of this study is to determine if the long-term efficacy outcome results obtained in single pilot studies can be replicated in a prospective, multi-center randomized controlled trail comparing the the esophageal cooling probe versus a standard of care esophageal temperature monitoring probe. There is a 50:50 chance of the esophageal cooling probe being used during AF ablation for participants.
详细描述
The purpose of this research project is to investigate if the long-term efficacy outcome (freedom from arrythmia) when using an esophageal cooling probe is potentially better than a standard of care temperature monitoring probe. This is the multi-center study is being done to confirm single center study results showing better long term efficacy. This study will also add to existing data showing reductions in esophageal injury with optional EGDs.
At present, the method of protection is limited; an esophageal temperature monitoring probe is inserted whilst the patient is under general anesthesia and the temperature is measured during ablation, stopping if temperatures markedly increase, which may suggest significant esophageal thermal injury. This method is unreliable as the temperature probe does not sit well in the esophagus and is often too far away from the area requiring monitoring. The probe is difficult to place as it can coil.
The esophageal cooling device (ensoETM) is another protection method that is gaining popularity since receiving marketing authorization from FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. While the acute safety data has been accepted, long-term efficacy outcomes improvements with use of ensoETM has not been confirmed outside of single center randomized studies.
The design of the project is in the form of a randomized controlled trial like the single-center studies, so participants will have a 50:50 chance of being allocated to the study group receiving the esophageal cooling probe (ensoETM) or to the control group, receiving the esophageal temperature monitoring probe.
The patient is blinded to the result of the randomization, to avoid bias/placebo effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participant is blinded to which esophageal probe is used (Esophageal cooling probe, [ensoETM] versus esophageal temperature monitoring probe) during their AF ablation, which is performed under general anesthesia.
This study includes an optional endoscopy. The endoscopist who performs the upper GI (gastrointestinal) endoscopy camera after the ablation procedure, is also blinded to the randomization.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AF patients scheduled to have a radiofrequency AF ablation procedure under general anesthesia who pass standard care screening assessments.
排除标准
- •Inability to consent for any reason.
- •Those in extremities of age (<18 or >85) will not be recruited.
- •AF patients scheduled to have a radiofrequency AF ablation under local anesthesia
- •Patients who have received a left atrial ablation procedure within the last 90 days. • • Patients enrolled in another clinical trial that might impact participation in this trial.
- •** For patients electing to undergo the optional endoscopy, no contraindications to endoscopy should be present
研究组 & 干预措施
Study group
Those randomized to the study group will receive the esophageal cooling device- the ensoETM probe, during AF ablation treatment, under general anaesthetic. The cooling device is set to 4 degrees Celsius during ablation of the left atrial posterior wall.
干预措施: ensoETM. Esophageal cooling during AF ablation (Device)
Control group
Those randomized to the control group will receive standard of care, which is an esophageal temperature monitoring probe during their AF ablation procedure, under general anesthetic. The esophageal temperature probe is placed close to the level of ablation (the probe should be at the esophageal level where, opposite this, the ablation catheter is at, in the endocardial aspect of the posterior left atrium).
干预措施: Esophageal temperature monitoring probe (Device)
结局指标
主要结局
Freedom from the treated atrial arrhythmia
时间窗: Measured at these time points: 3, 6, 12, months from time of ablation procedure.
Record any evidence of return of the treated arrhythmia at follow up cardiac monitoring: includes, 12 lead ECG, Holter, implantable loop recorders, non-invasive ECG monitors, mobile ECG apps. A return of AF (treated arrhythmia) must satisfy clear ECG/monitoring evidence of AF/related AT for \>30 seconds. This is a measure of the success of the AF ablation procedure.
次要结局
- Incidence of clinically significant chest/gastroenterological symptoms post ablation(Measured once at time points: 3 months from AF ablation procedure)
- Incidence and severity of endoscopically detected esophageal thermal injury related to AF ablation. (Endoscopy at times 12-72 hours).(Performed once, at 12-72 hours post ablation)
- Procedure duration (minutes).(Measured once. At time of AF ablation procedure (day 0))
- Fluoroscopy duration (minutes)(Measured once. At time of AF ablation procedure (day 0))
- Incidence of major adverse events (MACCE) at times 0, 3, 6, 12 months.(Measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.)
- Ability to attain procedural endpoints during AF ablation.(Measured once at time points: time of AF ablation procedure (day 0).)