Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A Randomized Study (AITAF)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- RF time to durable CTI block
研究概览
简要总结
A randomized controlled trial will be conducted to evaluate the efficacy of Ablation Index-guided high power - short duration (HPSD) ablation compared to conventional power settings in Cavotricuspid Isthmus (CTI) dependent atrial flutter. Participants will be randomized to receive either AI-guided HPSD ablation at 50 Watts or conventional power settings at 30 Watts. Both arms will use the Carto 3D mapping system and the QDOT MICRO ablation catheter (Biosense Webster). An anatomically contiguous line will be created with <6mm inter-lesion distance. After a standardized wait time of 30 minutes, ablation success will be assessed. The primary outcome is total radiofrequency ablation time. Secondary outcomes include procedural time, fluoroscopy time, safety outcomes, and 3-month freedom from recurrence. It is our expectation that HPSD will result in a shorter primary outcome.
详细描述
Title: A Randomized Trial of Ablation Index Guided High vs Standard Power Radiofrequency Ablation for Typical Atrial Flutter
Design: Prospective, two-arm, single center, superiority study with comparison of standard 30W power settings vs 50W high power settings
Purpose: To evaluate the superiority of high-power ablation settings over standard power settings in achieving block across the CTI for typical flutter
Enrollment: A minimum of 25 subjects in each arm. Enrollment over a period of 12 months.
Subjects: Subjects referred by a cardiac electrophysiologist for standalone radiofrequency ablation of typical atrial flutter
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
- Double (Participant, Outcomes Assessor)
盲法说明
Single-blinded. Investigator will know study arm, patients/participants will not. The outcomes assessor will be blinded.
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
- •Clinically determined by a cardiac electrophysiologist to have had at least one episode of CTI dependent atrial flutter
- •Clinically determined by a cardiac electrophysiologist likely to benefit from standalone CTI ablation
- •For this to be their first CTI ablation attempt
- •Able and willing to comply with all protocol requirements
- •Agree to and sign patient Informed Consent Form (ICF)
- •Be 18 years of age or older
排除标准
- •Previous CTI ablation
- •Adult congenital heart disease, including Ebstein's anomaly
- •Previous surgery involving the tricuspid valve and atrium including cannulation scars for cardiopulmonary bypass
- •Pediatric population age <18
- •Women who are pregnant or breastfeeding.
- •Active enrollment in another investigational study involving a drug or device.
- •A requirement for additional procedures in the same setting. Such as EP study and ablation of other induced arrhythmias since these prolong secondary endpoints such as procedure time and RF time
- •Patients on anti-arrhythmic drugs (AADs) such as flecainide, sotalol, or amiodarone should have their AAD stopped 3 days prior, and not be restarted after the procedure
- •Patients under General Anesthetic (GA)
- •Patients with sufficient baseline cognitive impairment to be unable to answer a post-procedure survey or consent Previous ablations, other than for CTI flutter, are acceptable.
结局指标
主要结局
RF time to durable CTI block
时间窗: End of procedure
Cumulative delivery time of radio-frequency lesions
次要结局
- Pericardial effusions(End of procedure day)
- RF time to initial CTI block(End of procedure)
- Total number of ablation lesions required to achieve durable CTI block(End of procedure)
- Total analgesia and sedation usage(End of procedure)
- Post-procedure patient perception of pain and nausea(End of procedure day)
- Total procedure time(End of procedure)
- Incidence of early re-connections during wait period(End of procedure)
- Steam pops(End of procedure)
- Pericardial tamponade(End of procedure day)
研究者
Rory Dowd
EP fellow
University of Calgary