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临床试验/NCT07012460
NCT07012460尚未招募不适用

Pulsed Field Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter Cohort Study

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Rate of acute severe coronary spasm

研究概览

简要总结

Pulsed field ablation (PFA) has been demonstrated to be safe and effective in achieving pulmonary vein isolation in patients with atrial fibrillation (AF). Coexisting atrial flutter is common in patients with AF. It is therefore appealing to treat the atrial futters with PFA. The use of PFA for extra-pulmonary ablation, such as linear ablation at the mitral or cavo-tricuspid isthmus (CTI) has been investigated. When PFA is applied near a coronary vessel, acute coronary spasm is a common observation, which has been reported to be reversible and largely mitigated by pre-emptive intravenous or intracoronary nitroglycerine (TNG) injection. A recent clinical study based on qualitative coronary angiogram reported no apparent coronary stenosis 6 months after PFA. However, quantitative measurements were not provided. While acute conduction block is easy to create with pulsed field ablation catheters, the long-term lesion durability is unknown. The circular array pulsed field ablation catheter was shown to be safe and effective in achieving pulmonary vein isolation. This study aims to evaluate the safety and efficacy of pulsed-field ablation for CTI flutters.

This study will be a multicenter prospective cohort study involving 30 patients undergoing ablation for atrial fibrillation and CTI flutter. The decision for ablation will be a clinical decision based on existing class I and II guideline recommendations.

The atrial fibrillation ablation procedure will be performed as per routine clinical practice. Procedure will be performed with a 3-D electro-anatomical system guidance. Pulmonary vein isolation (PVI) will be performed with pulsed field ablation with a circular array catheter (Pulse Select system, Medtronic). After confirming PVI, extrapulmonary ablation will be performed per clinically need. CTI ablation will be performed with PFA as planned.

Patient will be managed by usual clinical care after ablation. They will come back for follow up at 3 months for a remapping procedure. During the remapping procedure, a RCA coronary angiogram will be performed to exclude late coronary damage. A multipolar catheter will be inserted via right femoral vein to check for conduction block across CTI. If there is ongoing conduction, a repeat ablation will be performed with radiofrequency ablation.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with atrial fibrillation who are clinically planned to undergo AF ablation and atrial flutter ablation per guideline recommendations

排除标准

  • •>80 years old or <18 years old
  • •Known severe coronary artery disease
  • •Prior history of atrial flutter or atrial fibrillation ablation
  • •Refusal for remapping or coronary angiogram
  • •Contraindication for coronary angiogram
  • •Expected life expectancy <1 year
  • •Inability to provide informed consent

研究组 & 干预措施

CTI ablation

Other

CTI ablation will be performed with PFA. Coronary angiogram will be performed at baseline in LAO 45 degree before and after each set of ablations. The CTI block will be rechecked with 3D mapping system and multipolar catheter. If there is persistent CTI conduction, ablation will be repeated until CTI block is achieved. If CTI block cannot be achieved with repeated PFA ablation, ablation with radiofrequency will be allowed to achieve block. Patient will come back for follow up at 3 months for a remapping procedure. During the remapping procedure, a RCA coronary angiogram will be performed to exclude late coronary damage.

干预措施: CTI ablation (Device)

结局指标

主要结局

Rate of acute severe coronary spasm

时间窗: In 3 months follow up

Evaluate rate of acute severe coronary spasm induced by PFA (\>70% diameter reduction or ST change)

Rate of residual conduction

时间窗: In 3 months follow up

Evaluate rate of residual conduction across CTI in 3-month remapping

Rate of coronary artery damage

时间窗: In 3 months follow up

Evaluate rate of coronary artery damage in 3-month repeat coronary angiogram

次要结局

  • Rate of clinical recurrence of atrial arrhythmia(In 3 months follow up)
  • Number of PFA applications(In ablation procedure)
  • Rate of successful acute conduction block by PFA alone(In ablation procedure)
  • Rate of successful acute conduction block in all patients (with PFA or PFA + RFA)(In ablation procedure)
  • Number of mapping points in right atrium in electroanatomic system(In mapping procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tam Tsz Kin

Prof

Chinese University of Hong Kong

研究点 (1)

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