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

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ClinicalTrials.gov Identifier: NCT01013688
Recruitment Status : Unknown
Verified November 2009 by China National Center for Cardiovascular Diseases.
Recruitment status was:  Recruiting
First Posted : November 16, 2009
Last Update Posted : November 18, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Rheumatic Valve Disease Atrial Fibrillation Procedure: Cardioblate® Surgical Ablation System Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
Study Start Date : March 2008
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : May 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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: 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
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
No Intervention: Amiodarone group
No radiofrequency ablation procedure during the valve surgery; Amiodarone 200 mg/day for 12 months after surgery


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013688


Contacts
Contact: xin Wang, MD 86 10 15810210252 liuyedao21st@hotmail.com

Locations
China
Fuwai cardiovascular disease hospital Recruiting
Beijing, China, 100037
Contact: Wangxin , MD    86 10 15810210252    liuyedao21st@hotmail.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
Study Director: Shengshou Hu National center for cardiovascular disease ,china
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01013688     History of Changes
Other Study ID Numbers: Wangxin
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: November 18, 2009
Last Verified: November 2009

Keywords provided by China National Center for Cardiovascular Diseases:
Radiofrequency ablation
Maze
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Rheumatic Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Musculoskeletal Diseases
Connective Tissue Diseases
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors