search
Back to results

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

Primary Purpose

Rheumatic Valve Disease, Atrial Fibrillation

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cardioblate® Surgical Ablation System
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatic Valve Disease focused on measuring Radiofrequency ablation, Maze, Atrial fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fuwai cardiovascular disease hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

left atrial RF ablation groups

Bi-atrial radiofrequency ablation group

Amiodarone group

Arm Description

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

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

No radiofrequency ablation procedure during the valve surgery; Amiodarone 200 mg/day for 12 months after surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 11, 2009
Last Updated
November 16, 2009
Sponsor
China National Center for Cardiovascular Diseases
search

1. Study Identification

Unique Protocol Identification Number
NCT01013688
Brief Title
Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
Official Title
Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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 Standard 12-lead electrocardiography Holter-ECG Transthoracic echocardiography

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Valve Disease, Atrial Fibrillation
Keywords
Radiofrequency ablation, Maze, Atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
left atrial RF ablation groups
Arm Type
Experimental
Arm Description
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
Arm Title
Bi-atrial radiofrequency ablation group
Arm Type
Experimental
Arm Description
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
Arm Title
Amiodarone group
Arm Type
No Intervention
Arm Description
No radiofrequency ablation procedure during the valve surgery; Amiodarone 200 mg/day for 12 months after surgery
Intervention Type
Procedure
Intervention Name(s)
Cardioblate® Surgical Ablation System
Other Intervention Name(s)
radiofrequency
Intervention Description
Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with atrial fibrillation secondary to definite rheumatic valve disease At least six months and no longer than 5 years of chronic atrial fibrillation Age >=18 years and <=70 Patients who can give informed consent themselves in writing No contraindication for amiodarone 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 Left atrial diameter(LAD)>=70mm Left ventricular eject fraction(LVEF)<=30% Atrial thrombus Contraindication for anticoagulation therapy Less than 6 months since last episode of cerebral infarction Emergency operation Patients with a malignant tumor Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xin Wang, MD
Phone
86 10 15810210252
Email
liuyedao21st@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengshou Hu
Organizational Affiliation
National center for cardiovascular disease ,china
Official's Role
Study Director
Facility Information:
Facility Name
Fuwai cardiovascular disease hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wangxin, MD
Phone
86 10 15810210252
Email
liuyedao21st@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24820759
Citation
Wang X, Wang X, Song Y, Hu S, Wang W. Efficiency of radiofrequency ablation for surgical treatment of chronic atrial fibrillation in rheumatic valvular disease. Int J Cardiol. 2014 Jul 1;174(3):497-502. doi: 10.1016/j.ijcard.2014.03.153. Epub 2014 Mar 29.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs