EThanol administration under intraoperative His bundle potential monitoring for the purpose of predicting and preventing the occurrence of complete Atrioventricular block in Percutaneous tRansluminal sEptal myocarDIal ablation for obstruCTive hypertrophic cardiomyopathy

EThanol administration under intraoperative His bundle potential monitoring for the purpose of predicting and preventing the occurrence of complete Atrioventricular block in Percutaneous tRansluminal sEptal myocarDIal ablation for obstruCTive hypertrophic cardiomyopathy - ETHA-block-PREDICT study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220363

Enrollment

Registered

2022-10-05

Start date

2022-11-09

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hypertrophic obstructive cardiomyopathy

Interventions

The ethanol dose per target septal branch is 1.0-2.5 mL based on the guidelines of the Japanese Circulation Society. Ethanol is infused into the septal branch at less than 0.3 mL / min. At the time of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hypertrophic obstructive cardiomyopathy 2. Percutaneous transluminal septal myocardial ablation for left ventricular outflow tract obstruction 3. Optimal medical therapy such as beta blockers, group I antiarrhythmic drugs, and calcium channel blockers 4. Heart failure symptoms of NYHA IIm or higher, chest pain, or syncope 5. Left ventricular pressure gradient of 50 mmHg or more by echo or catheterization 6. Men and women over 40 years old 7. After receiving sufficient explanation for participation in this study, consent document by the patient's free will was obtained with sufficient understanding

Exclusion criteria

Exclusion criteria: 1. History of percutaneous transluminal septal myocardial ablation and surgical myectomy 2. Ventricular pacing after pacemaker or ICD implantation 3. After aortic valve or mitral valve replacement 4. After coronary artery bypass grafting 5. Mainly obstruction in the mid-ventricle 6. Untreated significant stenotic lesions in the coronary arteries 7. Contrast allergy 8. Bronchial asthma 9. Cre 2.0 mg/dL or higher (Exclude dialysis cases) 10. Severe alcohol hypersensitivity 11. During pregnancy, or women who may be pregnant 12. Patients judged by the investigator to be inappropriate as subjects

Design outcomes

Primary

Measure	Time frame
Incidence of complete atrioventricular block during percutaneous transluminal septal myocardial ablation	—

Secondary

Measure	Time frame
His-ventricular interval before and after ethanol administration by His bundle potential monitoring Ventricular wave of the His bundle potential recording PQ interval before and after ethanol administration Permanent pacemaker insertion rate Improvement rate of left ventricular pressure gradient after percutaneous transluminal septal myocardial ablation	—

Contacts

Public ContactDaigo Hiraya

University of Tsukuba Hospital

d.hiraya@md.tsukuba.ac.jp+81-29-853-3143

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026