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

Not Applicable

Recruiting

• Conditions: Hypertrophic obstructive cardiomyopathy

• Registration Number: JPRN-jRCTs031220363
• Lead Sponsor: Hiraya Daigo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of complete atrioventricular block during percutaneous transluminal septal myocardial ablation

Secondary Outcome Measures

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