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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031220725
Enrollment
10
Registered
2023-03-24
Start date
2023-03-24
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation and atrial tachycardia arrhythmia

Interventions

Catheter ablation with Vein of Marshall ethanol infusion

Sponsors

Fujiu Katsuhito
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 older than 18 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Incidence and rate of severe adverse events after chemical ablation

Secondary

MeasureTime frame
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

Contacts

Public ContactTsukasa Oshima

The University of Tokyo Hospital

tsuooshima-tky@g.ecc.u-tokyo.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026