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临床试验/NCT02321020
NCT02321020已完成不适用

Sinus Rhythm and Atrial Contractility Recovery After Radiofrequency Maze in Mitral Patients

Centro Cardiologico Monzino0 个研究点目标入组 168 人开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
168
主要终点
Sinus rhythm recovery

研究概览

简要总结

The present study aimed at evaluating mid-term results of radiofrequency modified maze procedure in mitral patients in terms of sinus rhythm and atrial contractility restoration

详细描述

Atrial fibrillation presents with different frequencies in patients affected by structural heart diseases requiring surgery, showing a peak incidence of up to 60-80% in mitral subjects. It causes an increased risk of systemic embolism, cardiac failure development and higher limitations due to dyspnoea and fatigue on exercise. Cox-Maze technique for surgical atrial fibrillation treatment was first used in 1987 and suffered lots of modifications since then. Nowadays, most centers have replaced the "cut and sew" technique by other methods using several power sources to achieve the same target in a much easier way. One of the alternative energy source currently used is radiofrequency ablation which has been demonstrated to be a simple, safe and reproducible procedure with an acceptable success rate in terms of sinus rhythm restoration. However, organized atrial activity (sinus rhythm on surface electrocardiogram) is not always accompanied by an effective mechanical atrial contraction, whose restoration represents one of the original Maze objective. Atrial contraction is effective when A waves are found in tricuspid and/or mitral transvalvular flow using Doppler echocardiography, allowing the patient to fully profit from hemodynamic and clinical advantages of an organized atrial contraction. Predictive factors of atrial contractility recovery and, more widely, of sinus rhythm achievement after modified Maze procedures have been investigated, but, at our knowledge, a parallel deep analysis and comparison of possible determinants of both surgical ablation goals is still lacking. In the present study, the investigators describe mid-term results of concomitant modified radiofrequency Maze in a large homogeneous population of mitral patients, focusing onto common predictors of sinus rhythm and atrial contractility restoring, their time course appearance and interrelation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients affected by atrial fibrillation undergoing mitral valve surgery

排除标准

  • Other cardiac procedures in addition to mitral valve surgery

结局指标

主要结局

Sinus rhythm recovery

时间窗: 5 years

Early postoperative rhythms were checked in all patients daily by standard 12-channel surface electrocardiogram. Follow up 24 hours Holter monitoring was checked postoperatively at 3,6,12 and 24 months after the intervention and then annually.

次要结局

  • Left atrial contractility recovery after maze(24 months)

研究者

发起方
Centro Cardiologico Monzino
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Loardi

MD

Centro Cardiologico Monzino

相似试验

Follow up of Radiofrequency Maze in Mitral Patients | 临床试验