跳至主要内容
临床试验/NCT00238706
NCT00238706已完成不适用

Left Atrial Radiofrequency Ablation During Mitral Valve Surgery for Continuous Atrial Fibrillation: A Prospective Randomized Clinical Trial

University Hospitals, Leicester0 个研究点开始时间: 2001年12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
主要终点
The primary outcome endpoint was the presence of SR at 12 months

研究概览

简要总结

The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial radiofrequency ablation during MV surgery for the treatment of continuous atrial fibrillation and to assess the functional effects of restoration of sinus rhythm.

详细描述

Atrial fibrillation (AF) is a frequent and important contributor to symptoms and morbidity in patients with mitral valve (MV) disease.Radiofrequency ablation (RFA) of the left atrium (LA) during open- heart surgery has emerged as a novel surgical modality for the treatment of AF. Although RFA therapy of the LA is being increasingly offered to patients with chronic AF undergoing MV surgery, its efficacy has not been tested in the context of an adequately powered randomized study. The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial RFA during MV surgery for the treatment of continuous AF and to assess the functional effects of restoration of SR.

Patients were randomized to undergo MV surgery or MV surgery plus RFA of the LA. Additional cardiac procedures were performed as required.

The primary outcome endpoint was the presence of SR at 12 months. Secondary endpoints included patient functional status and exercise capacity, LA contractility, and LA and left ventricular (LV) dimension and function and plasma levels of B-Type natriuretic peptide (BNP).

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
Single

入排标准

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

入选标准

  • Patients requiring MV surgery with at least 6 month history of atrial fibrillation

排除标准

  • Patients with sick sinus syndrome
  • Hyperthyroidism
  • Permanent pacemaker
  • Previous cardiac surgery

结局指标

主要结局

The primary outcome endpoint was the presence of SR at 12 months

次要结局

  • Secondary endpoints included:
  • patient functional status and exercise capacity
  • Left atrial contractility
  • Left atrial and left ventricular dimension and function Plasma levels of B-Type natriuretic peptide (BNP).

研究者

发起方
University Hospitals, Leicester
申办方类型
Other

相似试验