Multi-catheter Cryotherapy Versus Radiofrequency Catheter Ablation for the Treatment of Standard and Resistant Arrhythmias
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Recurrence of the treated arrhythmia at 12 months
研究概览
简要总结
A program of research has been set up at St. George's Hospital, London studyng the practicalities of catheter ablation. The current practice of catheter ablation is being studied for a range of arrhythmias including PAF, persistent AF, advanced persistent AF and resistant WPW.
详细描述
The study design will be a separate randomised clinical trial for each of the arrhythmias studied. There will be 1:1 randomisation to either the cryotherapy protocol or RF protocol. Arrhythmia patients already under the care of this cardiac centre, who have already opted for catheter ablation treatment will be approached to ask if they will also be willing to participate in this longterm research program.
The protocols for each different arrhythmia are in line with current practice and knowledge and utilising current technology. In the program, the investigators have 1 or 2 protocols that mildly differ from conventional use but have already passed through initial experience with publication on this- this is the multi-catheter cryocatheter approach.
Acute procedural outcomes, short, medium and longterm success will be recorded for each patient, in addition to patient or participant experience and quality of life outcomes.
The catheter ablation research program has passed through ethical panel review in London and has the potential to become a multi-centre study.
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
- Single (Outcomes Assessor)
盲法说明
The physiologist analysing the Holter results and/or loop recorders for recurrence of arrhythmia will not know the randomised treatment for the study participant.
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients under the care of the Arrhythmia Service at St. George's Hospital with one of the studied arrhythmia (PAF, persistent AF etc), awaiting catheter ablation treatment will be eligible for inclusion to the program of research
排除标准
- •Vulnerable patients will be excluded- e.g. active cancer, inability to consent
- •Paediatric patients will not be studied
- •Patients awaiting standard SVT catheter ablation treatment
研究组 & 干预措施
Cryotherapy
Cryotherapy ablation energy will be utilised in the catheter ablation procedure
干预措施: Cryotherapy (Procedure)
Radiofrequency
Radiofrequency ablation energy will be utilised in the catheter ablation procedure
干预措施: radiofrequency catheter ablation (Procedure)
结局指标
主要结局
Recurrence of the treated arrhythmia at 12 months
时间窗: 12 months
Recurrence of the treated arrhythmia or related tachycardia will be recorded in a single timeframe of 12 months. The method for recording recurrence will be from Holter or via loop recorder download.
Recurrence of the treated arrhythmia at 6 months
时间窗: 6 months
Recurrence of the treated arrhythmia or related tachycardia will be recorded in a single timeframe of 6 months. The method for recording recurrence will be from Holter or via loop recorder download.
Recurrence of the treated arrhythmia at 24 months
时间窗: 24 months
Recurrence of the treated arrhythmia or related tachycardia will be recorded in a single timeframe of 24 months. The method for recording recurrence will be from Holter or via loop recorder download.
次要结局
- To record the patient quality of life improvement by filling in a Short Form-36 questionnaire(24 months)
- The rate of major adverse cerebrovascular and/or cardiovascular complications (defined as MI, CVA, vascular, oesophageal trauma, phrenic nerve injury) will be recorded(24 months)
研究者
Dr. Mark M. Gallagher
Consultant Cardiologist and electrophysiologist
St. George's Hospital, London