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临床试验/NCT07456540
NCT07456540尚未招募不适用

Comparison of Available Standard Methods for Pulmonary Vein Isolation for Ablation Treatment of Atrial Fibrillation

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 1,125 人开始时间: 2026年2月15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
1,125
试验地点
1
主要终点
Atrial fibrillation or atrial flutter

研究概览

简要总结

The goal of this cluster randomization study is to evaluate currently used standard methods for pulse field ablation in patients with irregular heart rhythm also called atrial fibrillation (AF) who are treated at Rigshospitalet and Gentofte Hospital in Copenhagen, Denmark.

A cluster randomization study tests standardized treatments by rotating the treatments over time periods. All patients will be treated with the specific standard treatment of the period and will be informed about the study. The patient will have the option to decline their participatiion in the study in writing and their data will not be collected.

The main purpose of the study is to investigate whether one of more of the systems are more efficient in preventing AF or atrial flutter during the following 12 months. Additionally, the safety of the systems are compared to see if one or more are more efficient in preventing complications 30 days after the ablation procedure.

The patients will receive standard treatment according to the cluster at the time of their ablation and data for up to 12 months post procedure will be collected by medicial chart review.

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)

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

  • 18 years or older
  • Planned Catheter Ablation of Atrial Fibrillation with Pulmonary Vein Isolation

排除标准

  • - Opt out of data collection

研究组 & 干预措施

FARAPULSE and FARAVIEW

Active Comparator

PFA system

干预措施: Pulse field ablation Systems (Device)

VARIPULSE

Active Comparator

PFA system

干预措施: Pulse field ablation Systems (Device)

PULSE-SELECT and AFFERA

Active Comparator

PFA system

干预措施: Pulse field ablation Systems (Device)

Arctic Front Advance Cardiac Cryoablation Catheter

Active Comparator

Ablation system

干预措施: Pulse field ablation Systems (Device)

VOLT

Active Comparator

PFA system

干预措施: Pulse field ablation Systems (Device)

结局指标

主要结局

Atrial fibrillation or atrial flutter

时间窗: 12 months post procedure

Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)

Atrial fibrillation or atrial flutter

时间窗: 6 months post procedure

Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)

Atrial fibrillation or atrial flutter

时间窗: 3 months post procedure

Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)

次要结局

  • Hospitalization due to atrial fibrillation or flutter(12 months post procedure)
  • Hospitalization due to atrial fibrillation or flutter(6 months post procedure)
  • Patient reported outcome measures(12 month)
  • Patient reported outcomes measures(6 month)
  • Patient reported outcomes measures(3 month)
  • Antiarrhythmic medications(12 months post procedure)
  • Antiarrhythmic medications(6 months post procedure)
  • Duration of the procedure(Post procedure)
  • Safety of the system(30 days post procedure)

研究者

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

Peter Karl Jacobsen

MD

Rigshospitalet, Denmark

研究点 (1)

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