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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

Page last updated: August 23, 2015

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