The Contact-CTI Study - Does Assessment of Tissue Contact During Ablation of Atrial Flutter Improve Outcomes?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- The primary outcome measure is the mean ablation time required to achieve the acute procedural endpoint of cavotricuspid isthmus conduction block
研究概览
简要总结
This study will be a single blind prospective randomised control trial in patients undergoing ablation for the treatment of typical atrial flutter, with the aim of investigating the benefit of a new impedance-based computer software application which measures tissue contact between the ablation catheter and the inside of the heart.
The investigators hope to demonstrate that the use of this tissue contact information reduces ablation time, Xray time, and procedure time required to complete the procedure successfully. Study participants will be randomly assigned to undergo their procedure with or without this contact data displayed for the doctor performing the ablation to see. The acute procedural endpoint of ablation is successful conduction block across the cavotricuspid isthmus of the right atrium. If the outcome of this study is positive, it will have a significant beneficial impact on this procedure, reducing procedure length, patient discomfort, and potentially reducing risk for the patient, recurrent arrythmia symptoms, and the need for repeat procedures later on.
详细描述
Patients in this study will be de novo cases of atrial flutter ablation, and they will be randomised to ablation using tissue contact data provided by the St. Jude medical ECI technology (active arm), or standard ablation as per physician practice, without the use of contact data to guide ablation (control arm). The endpoint measures will include RF ablation time, procedure time, time to achieving cavotricuspid isthmus block, the need for "touch up" ablation to achieve conduction block, the recurrence rate of isthmus conduction on isuprel infusion at 20 minutes post-isolation, and clinical recurrence of atrial flutter post-operatively.
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 (Participant)
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
- •Patient is undergoing de novo cavotricuspid isthmus ablation.
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or over
排除标准
- •(1) Previous percutaneous or open surgical procedure involving the right atrium
研究组 & 干预措施
ECI CONTACT-ACTIVE
Irrigated Radiofrequency ablation performed using the ECI contact data
干预措施: Radiofrequency ablation utilising the ECI contact software (Procedure)
ECI CONTACT-INACTIVE
irrigated RF ablation performed to the right atrium without the use of ECI contact data
干预措施: Radiofrequency ablation without the use of ECI contact data (Procedure)
结局指标
主要结局
The primary outcome measure is the mean ablation time required to achieve the acute procedural endpoint of cavotricuspid isthmus conduction block
时间窗: immediate (intra-procedural)
次要结局
未报告次要终点