Status:
UNKNOWN
Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Lone Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) increases risks of stroke, heart failure and sudden death. Single catheter ablation only has a low success rate due to inadequate transmurality and continuity of the lesion li...
Eligibility Criteria
Inclusion
- Isolated atrial fibrillation, without structural heart disease.
- Failed medical treatment
- Patient admitted with intent to be treated by surgical ablation
Exclusion
- Previous surgical ablation of atrial fibrillation
- Concomitant other cardiac diseases which require surgery at the same procedure, such as heart valve disease, congenital heart disease, coronary disease, dilated cardiomyopathy etc.
- With other forms of severe arrhythmia
- Ejection fraction of left ventricle less than 30%
- Anteroposterior diameter of left atrial over 60mm
- Tumor, active infection, pregnancy.
- Previous surgeries with left thoracotomy, or expected left pleural adhesion, such as history of tuberculosis infection, pleural effusion, pneumothorax etc.
- Hyperthyroidism
- Thrombosis within left atrial appendage
- General conditions too weak to tolerate the surgeries
- Patient's circumstance that precludes completion of follow-up and/or obtaining information from the 6 months follow-up
- Other conditions not appropriate for this study based on the investigators' judgments
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04522024
Start Date
October 1 2020
End Date
September 30 2023
Last Update
August 21 2020
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