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

JRCT ID: jRCTs031220363

Registered date:05/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertrophic obstructive cardiomyopathy
• Date of first enrollment: 09/11/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): 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 administration of 1/3 of the total amount of ethanol, the PQ interval and the His-ventricular interval of the His bundle potential are measured. Ethanol administration is discontinued when His-ventricular interval is extended by 20% at baseline.

Outcome(s)

• Primary Outcome: Incidence of complete atrioventricular block during percutaneous transluminal septal myocardial ablation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hiraya Daigo
• Source(s) of Monetary Support: Japan Society for the Promotion of Science