JRCT ID: jRCT1072230115
Registered date:08/02/2024
Optimal Power on Left Atrial Wall on Esophagus in Radiofrequency Catheter Ablation for Atrial Fibrillation
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | atrial fibrillation |
Date of first enrollment | 01/02/2024 |
Target sample size | 50 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | All patients undergo radiofrequency catheter ablation with a QDOT MICRO catheter using a 3D mapping system (CARTO3). We apply radiofrequency on the left atrial wall on the esophagus using QMODE+. Patients are randomly assigned to power settings of 60W and 90W. All patients underwent esophageal endoscopy to evaluate esophageal lesions on the day after the ablation procedure. |
Outcome(s)
Primary Outcome | Residual conduction gap on esophagus after linear radiofrequency application for left atrial wall on the esophagus. |
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Secondary Outcome | Esophageal lesion classified by Kansas City classification. Gastric hypomotility Residual conduction gap after ipsilateral circumferential linear radiofrequency application around the pulmonary vein. The time needed to complete linear radiofrequency application around the pulmonary vein Procedure-related complication |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | |
Include criteria | Patients undergoing first radiofrequency catheter ablation for atrial fibrillation. |
Exclude criteria | Patients participating in other clinical trials. Patients with a history of catheter ablation and/or surgery of atrial fibrillation. Patients with left ventricular ejection fraction less than 35 percent. Patients with left atrial diameter greater than 55 millimeters. Patients with persistent atrial fibrillation lasting more than three years. Patients with a history of surgical or catheter intervention for valvular heart disease. Patients with severe valvular heart disease Patients with a history of esophageal varices Patients with active malignancy |
Related Information
Primary Sponsor | Okamatsu Hideharu Hideharu |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Hideharu Okamatsu |
Address | 5-3-1 Chikami, Minami-ku, Kumamoto City, Kumamoto Kumamoto Japan 8614193 |
Telephone | +81-96-351-8000 |
hideharu-okamatsu@saiseikaikumamoto.jp | |
Affiliation | Saiseikai Kumamoto Hospital |
Scientific contact | |
Name | Hideharu Hideharu Okamatsu |
Address | 5-3-1 Chikami, Minami-ku, Kumamoto City, Kumamoto Kumamoto Japan 8614193 |
Telephone | +81-96-351-8000 |
hideharu-okamatsu@saiseikaikumamoto.jp | |
Affiliation | Saiseikai Kumamoto Hospital |