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临床试验/NCT05368610
NCT05368610Unknown不适用

Effect of Very High Power-short Duration Ablation on Lesion Contiguity in Pulmonary Vein Isolation as Assessed by Late Gadolinium Enhancement Cardiovascular Magnetic Resonance

University of Barcelona1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年3月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
128
试验地点
1
主要终点
Ablation lesion contiguity as assessed by LGE-CMR

研究概览

简要总结

This observational trial investigates the effect of very high power-short duration radiofrequency ablation on lesion contiguity as assessed by late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR). Patients with paroxysmal or early persistent atrial fibrillation (AF) scheduled for pulmonary vein isolation (PVI) undergo point-by-point ablation using the QDOT micro catheter applying Qmode+ (90W over 4 seconds). All patients receive an LGE-CMR 3 months after the procedure for ablation lesion assessment. Contiguity of LGE-CMR-detected ablation lesions will be compared with a matched control group of patients that have undergone PVI accomplished by ablation index-guided ablation with 40 W following the CLOSE protocol.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • paroxysmal or early persistent (max. 3 months) atrial fibrillation
  • scheduled for PVI-only catheter ablation

排除标准

  • long-standing persistent atrial fibrillation
  • previous left atrial ablation
  • claustrophobia preventing CMR
  • sever renal insufficiency (GFR >30 ml/min)
  • gadolinium contrast allergy
  • presence of implantable devices not compatible with magnetic resonance
  • pregnancy and lactation

结局指标

主要结局

Ablation lesion contiguity as assessed by LGE-CMR

时间窗: LGE-CMR at 3 months post-ablation

Proportion of the circumferential ablation line covered by LGE (%)

次要结局

未报告次要终点

研究者

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

Till F. Althoff

Staff, Arrhythmia Section, Department of Cardiology, Hospital Clinic de Barcelona

University of Barcelona

研究点 (1)

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