NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedatrial fibrillation
Date of first enrollment01/02/2024
Target sample size50
Countries of recruitment
Study typeInterventional
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 OutcomeResidual conduction gap on esophagus after linear radiofrequency application for left atrial wall on the esophagus.
Secondary OutcomeEsophageal 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 minimumNot applicable
Age maximumNot applicable
Gender
Include criteriaPatients undergoing first radiofrequency catheter ablation for atrial fibrillation.
Exclude criteriaPatients 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

Contact

Public contact
Name Hideharu Okamatsu
Address 5-3-1 Chikami, Minami-ku, Kumamoto City, Kumamoto Kumamoto Japan 8614193
Telephone +81-96-351-8000
E-mail 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
E-mail hideharu-okamatsu@saiseikaikumamoto.jp
Affiliation Saiseikai Kumamoto Hospital