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临床试验/NCT05319769
NCT05319769已完成不适用

Non Fluoroscopic APpROach iN atriaL Fibrillation Ablation procEdureS

University Hospital of Ferrara1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
DAP

研究概览

简要总结

In electrophysiology, interventional procedures are often assisted by fluoroscopic guidance, exposing both patients and healthcare professionals to a considerable dose of radiation. Catheter ablation of atrial fibrillation has frequently involved the use of fluoroscopy: in fact, it incorporates greater complexity due to the need to perform the transseptal puncture.

A visible introducer in the 3D electro-anatomical mapping system (which does not involve the use of X-rays), has become an important tool for performing transseptal puncture: in particular, it is positioned at level of the oval fossa of the right atrium (puncture site); subsequently, the needle is introduced inside it; the intervention is guided both by electroanatomical mapping and by the use of intracardiac echocardiography for the identification of important anatomical landmarks.

The "zero rays" technique represents a valid alternative to fluoroscopic guidance, widely used and validated over the years. In fact, X-ray exposure in an atrial fibrillation ablation procedure can reach up to 60 mSv: the radiological risk makes it necessary to study safe and effective alternative techniques.

In this retrospective, observational and monocentric study, 50 catheter ablation procedures of atrial fibrillation will be examined, divided into two groups:

  1. 25 patients who performed this procedure according to the classic approach, ie under fluoroscopic guidance;
  2. 25 patients who performed this procedure using an ablative approach that involved the use of the introducer in combination with the 3D EAM system and intracardiac echocardiography.

Clinical efficacy will be assessed through a cardiological checkup and 24-hour electrocardiographic recording (ECG Holter) at 6 months.

详细描述

Atrial fibrillation (AF) is the most common sustained adult tachyarrhythmia found in clinical practice. The prevalence of this arrhythmia in the general population varies from 2 to 4% and increases significantly in elderly patients and in carriers of diseases such as arterial hypertension, heart failure, coronary and valvular disease, obesity, diabetes mellitus and chronic kidney disease. In addition to being a marker of underlying heart or vascular disease, FA in itself is accompanied by an increased incidence of ischemic stroke, heart failure and dementia. The mechanisms underlying this arrhythmia are still debated, but seem to involve electrical and structural alterations of the atrium that constitute a morpho-functional substrate that facilitate its development.

Traditionally, five types of atrial fibrillation are distinguished, based on presentation, duration and term:

  1. Newly diagnosed AF: first finding of AF, regardless of the duration, presence and severity of symptoms;
  2. Paroxysmal AF: AF that resolves within seven days (spontaneously or through cardioversion);
  3. Persistent AF: AF that lasts more than seven days or is cardioverted after seven days;
  4. Long lasting AF: AF that lasts more than a year continuously, when a rhythm control strategy has been adopted.
  5. Permanent AF: AF accepted by the patient (and by the attending physician) for which no further attempt to control the rhythm is undertaken.

Treatment include heart rate and / or rhythm control strategies, prevention of cerebral thromboembolism and reduction / elimination of symptoms, as well as control of major cardiovascular risk factors. The decision about the implementation of therapeutic strategies aimed at restoring and maintaining sinus rhythm must be shared between doctor and patient, weighing on the one hand the effect on quality of life and symptoms, and on the other the risk of toxic effects of drugs. used. When AF has been on for less than a year, an early rhythm control strategy has been shown to reduce the composite outcome of cardiovascular death, stroke, hospitalization for heart failure or acute coronary syndrome in the EAST-AFNET 4 clinical trial.

Trans catheter ablation is a well-established treatment for the reduction of AF relapses and is proposed in cases of paroxysmal and persistent AF. It is a procedure that consists in the antral circumferential disconnection of the pulmonary veins by radiofrequency, laser or cryoblation. It is a safe and effective technique for maintaining sinus rhythm and for improving symptoms. When antiarrhythmic drugs fail in rhythm control, the current ESC 2020 Guidelines place trans-catheter ablation in class I for paroxysmal and persistent AF with or without major risk factors for recurrence, while as a first therapeutic approach it is in class IIa for paroxysmal AF and IIb for persistent AF without major risk factors for relapse.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Paroxysmal or persistent atrial fibrillation
  • Atrial fibrillation ablation performed during study period
  • Clinical follow-up and ECG-Holter recording during follow-up

排除标准

  • Age < 18 years
  • Pregnancy

结局指标

主要结局

DAP

时间窗: Intraprocedure

Dose area product

Procedural time

时间窗: Intraprocedure

Total procedure time

Fluoroscopy time

时间窗: Intraprocedure

Time of X-ray exposure

次要结局

  • Time for PVI(Intraprocedure)
  • Complications(30 days)
  • Absence of atrial fibrillation recurrence(6 months)

研究者

发起方
University Hospital of Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Bertini

Principal Investigator

University Hospital of Ferrara

研究点 (1)

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