Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
Information source: China National Center for Cardiovascular Diseases
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatic Valve Disease; Atrial Fibrillation
Intervention: Cardioblate® Surgical Ablation System (Procedure)
Phase: Phase 3
Status: Recruiting
Sponsored by: China National Center for Cardiovascular Diseases Official(s) and/or principal investigator(s): Shengshou Hu, Study Director, Affiliation: National center for cardiovascular disease ,china
Overall contact: xin Wang, MD, Phone: 86 10 15810210252, Email: liuyedao21st@hotmail.com
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.
Clinical Details
Official title: Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
xin Wang, MD, Phone: 86 10 15810210252, Email: liuyedao21st@hotmail.com
Fuwai cardiovascular disease hospital, Beijing 100037, China; Recruiting Wangxin , MD, Phone: 86 10 15810210252, Email: liuyedao21st@hotmail.com
Additional Information
Starting date: March 2008
Last updated: November 16, 2009
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