Exploratory interventional research for the ethanol infusion for atrial fibrillation and atrial tachycardia

JRCT ID: jRCTs031220725

Registered date:24/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: atrial fibrillation and atrial tachycardia
• Date of first enrollment: 24/03/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Catheter ablation with Vein of Marshall ethanol infusion

Outcome(s)

• Primary Outcome: Incidence and rate of severe adverse events after chemical ablation

Secondary Outcome

1. Incidence and rate of adverse events after chemical ablation
2. Incidence and rate of adverse events related to ethanol injection procedure
3. Rate of successful procedure completion
4. Rate of maintenance of sinus rhythm at discharge

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

[Primary Enroll]
1. Diagnosed with atrial tachycardia or atrial fibrillation (paroxysmal or persistent) , including patients who have received catheter ablation
2. Scheduled to have a catheter ablation
3. Aged from 18 to 85 years at the time of informed consent
4. Male or female
5. Able to attend all scheduled visits
6. Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation

[Secondary Enroll]
Unable to be treated successfully with conventional catheter ablation:
1. Unable to perform linear ablation
2. Unable to complete pulmonary vein isolation due to electrical connection between pulmonary vein and Vein of Marshall
3. Arrhythmia originating from Vein of Marshall

Exclude criteria

[Primary Enroll]
1. With defect of Vein of Marshall
2. With ethanol allergy
3. With severe liver failure: e.g. total bilirubin of above 3.0 mg/dL and with uncontrolled ascites
4. With severe hemorrhagic diathesis, except for anticoagulant therapy
5. Taking drugs for alcoholism: disulfiram and cyanamide
6. Judged as ineligible by clinical investigators

[Secondary Enroll]
1. With defect or stenosis of vein of Marshall
2. Judged as treated successfully with conventional catheter ablation procedure by clinical investigators
3. Judged as ineligible by clinical investigators

Related Information

• Primary Sponsor: Fujiu Katsuhito