Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | November 11, 2009 | ||||
| Last Updated Date | November 16, 2009 | ||||
| Start Date ICMJE | March 2008 | ||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01013688 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease | ||||
| Official Title ICMJE | Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease | ||||
| 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. |
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| 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
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Cardioblate® Surgical Ablation System
Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery
Other Name: radiofrequency |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | May 2010 | ||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Any one of the following exclusion criteria is sufficient to disqualify a patient from the study
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01013688 | ||||
| Other Study ID Numbers ICMJE | Wangxin | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | China National Center for Cardiovascular Diseases | ||||
| Study Sponsor ICMJE | China National Center for Cardiovascular Diseases | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | China National Center for Cardiovascular Diseases | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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