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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01013688
• Other study ID #: Wangxin
• Status: Recruiting
• Phase: Phase 3
• First received: November 11, 2009
• Last updated: November 16, 2009
• Start date: March 2008
• Est. completion date: May 2010

Study information

• Verified date: November 2009
• Source: China National Center for Cardiovascular Diseases
• Contact: xin Wang, MD
• Phone: 86 10 15810210252
• Email: liuyedao21st[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Rheumatic Diseases
• Rheumatic Valve Disease

Intervention

Procedure:
• Cardioblate® Surgical Ablation System
Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery

Locations

Country	Name	City	State
China	Fuwai cardiovascular disease hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes