NCT01013688

Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 rheumatic valve patients with chronic atrial fibrillation (AF) having concomitant valve surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation group, and Amiodarone group. All patients were scheduled followed up before discharge and at 3rd, 6th and 12th postoperative months. Standard 12-lead electrocardiography (ECG), 24-hour Holter and transthoracic echocardiography were used to determine the rhythm and cardiac hemodynamic status.

Detailed description

The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control,improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 patients with chronic AF having concomitant cardiac surgery will be enrolled. Patients will underwent bi-atrial radiofrequency,left atrial radiofrequency or no radiofrequency procedure randomly. All the patients will receipt amiodarone 200 mg/day for 12 months postoperatively. All patients were scheduled followed before discharge and at 3rd, 6th and 12th postoperative months.The following diagnostic procedures were performed 1. Standard 12-lead electrocardiography 2. Holter-ECG 3. Transthoracic echocardiography

Conditions

• Rheumatic Valve Disease
• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Cardioblate® Surgical Ablation System	Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-05-01
• Completion: 2010-05-01
• First posted: 2009-11-16
• Last updated: 2009-11-18

Locations

1 site across 1 country: China