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

November 16, 2009 updated by: China National Center for Cardiovascular Diseases
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Fuwai cardiovascular disease hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • radiofrequency
No Intervention: Amiodarone group
No radiofrequency ablation procedure during the valve surgery; Amiodarone 200 mg/day for 12 months after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Study Director: Shengshou Hu, National center for cardiovascular disease ,china

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

May 1, 2009

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

November 11, 2009

First Submitted That Met QC Criteria

November 13, 2009

First Posted (Estimate)

November 16, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2009

Last Update Submitted That Met QC Criteria

November 16, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wangxin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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