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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01013688

Enrollment

150

Registered

2009-11-16

Start date

2008-03-31

Completion date

2010-05-31

Last updated

2009-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Rheumatic Valve Disease

Keywords

Radiofrequency ablation, Maze, Atrial fibrillation

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 1. Standard 12-lead electrocardiography 2. Holter-ECG 3. Transthoracic echocardiography

Interventions

PROCEDURECardioblate® Surgical Ablation System

Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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	1 year

Countries

China

Contacts

Primary Contactxin Wang, MD

liuyedao21st@hotmail.com86 10 15810210252

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026