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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by China National Center for Cardiovascular Diseases.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT01013688
First received: November 11, 2009
Last updated: November 16, 2009
Last verified: November 2009

November 11, 2009
November 16, 2009
March 2008
May 2009   (final data collection date for primary outcome measure)
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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01013688 on ClinicalTrials.gov Archive Site
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Not Provided
Not Provided
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Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rheumatic Valve Disease
  • Atrial Fibrillation
Procedure: Cardioblate® Surgical Ablation System
Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery
Other Name: radiofrequency
  • Experimental: left atrial RF ablation groups
    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
    Intervention: Procedure: Cardioblate® Surgical Ablation System
  • Experimental: Bi-atrial radiofrequency ablation group
    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
    Intervention: Procedure: Cardioblate® Surgical Ablation System
  • No Intervention: Amiodarone group
    No radiofrequency ablation procedure during the valve surgery; Amiodarone 200 mg/day for 12 months after surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
May 2010
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: xin Wang, MD 86 10 15810210252 liuyedao21st@hotmail.com
China
 
NCT01013688
Wangxin
Yes
China National Center for Cardiovascular Diseases
China National Center for Cardiovascular Diseases
Not Provided
Study Director: Shengshou Hu National center for cardiovascular disease ,china
China National Center for Cardiovascular Diseases
November 2009

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