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

Phase 3

• Conditions: Rheumatic Valve Disease; Atrial Fibrillation
• Interventions: Procedure: Cardioblate® Surgical Ablation System

• Registration Number: NCT01013688
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-05
• Status Verified: 2009-11
• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Last Update Submitted: 2009-11-16
• Last Update Posted: 2009-11-18
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients with atrial fibrillation secondary to definite rheumatic valve disease
2. At least six months and no longer than 5 years of chronic atrial fibrillation
3. Age >=18 years and <=70 Patients who can give informed consent themselves in writing
4. No contraindication for amiodarone
5. Negative pregnancy test (in women with childbearing potential)

Exclusion Criteria

Any one of the following exclusion criteria is sufficient to disqualify a patient from the study

1. Left atrial diameter(LAD)>=70mm
2. Left ventricular eject fraction(LVEF)<=30%
3. Atrial thrombus
4. Contraindication for anticoagulation therapy
5. Less than 6 months since last episode of cerebral infarction
6. Emergency operation
7. Patients with a malignant tumor
8. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
9. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
left atrial RF ablation groups	Cardioblate® Surgical Ablation System	Excised the left atrial appendage Encircling the left pulmonary veins and an extension to the posterior mitral valve annulus From the left atrial appendage to the left superior pulmonary vein A connecting line between both islands of pulmonary veins From the middle of the mitral valve ablation line down towards the base of the atria ligament of Marshall
Bi-atrial radiofrequency ablation group	Cardioblate® Surgical Ablation System	In the basis of left atrial group,excised the right atrial appendage; from the amputated right atrial appendage towards the inferior vena cava; from the midterm of interatrial septum to the AV groove; ablation between the superior and inferior caval cannulation sites; radiofrequency ablation for Waterston's groove

Primary Outcome Measures

Name	Time	Method
At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography	1 year

Trial Locations

Locations (1)

Fuwai cardiovascular disease hospital; 🇨🇳 Beijing, China