Periprocedural Cerebral Embolism by Catheter Ablation of Atrial Fibrillation

JRCT ID: jRCT1052210013

Registered date:30/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: atrial fibrillation
• Date of first enrollment: 26/05/2021
• Target sample size: 230
• Study type: Interventional

Intervention(s)

control group: radiofrequency catheter ablation of atrial fibrillation
intervention group: cryoballoon ablation of atrial fibrillation

Outcome(s)

• Primary Outcome: 1. cerebral embolism (silent cerebral events) by brain MRI during the acute phase of catheter ablation

Secondary Outcome

safety
1. cerebral embolism (silent cerebral lesions) by brain MRI during the acute phase of catheter ablation
2. cerebral embolism by brain MRI 1 month after
3. number of micro-embolic signals during catheter ablation
4. mico-hemorrhag e during the acute phase and 1 month after catheter ablation
5. complication of catheter ablation
efficacy
1. success rate of catheter ablation during the acute phase
2. success rate of catheter ablation 1 year after catheter ablation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. aged 20-85 years old
2. diagnosed as atrial fibrillation
3. planned radiofrequency or cryoballoon catheter ablation of atrial fibrillation
4. written informed consent

Exclude criteria

1. history of catheter ablation and/or surgery of atrial fibrillation
2. left atrial dimension more than 55 mm
3. inability to take brain MRI
4. pregnant
5. concomittant participation in intervention study with other medication and/or medical instrument
6. patients whom doctors responsible for this study judge inappropriate

Related Information

• Primary Sponsor: Kusano Kengo