Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy

Xiang Wei1 site in 1 country100 target enrollmentNovember 15, 2022

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Xiang Wei
Enrollment: 100
Locations: 1
Primary Endpoint: Procedural success
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.

Registry

clinicaltrials.gov

Start Date

November 15, 2022

End Date

December 30, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xiang Wei

Responsible Party

Sponsor Investigator

Principal Investigator

Xiang Wei

Division of Cardiothoracic and Vascular Surgery

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

•Patients who were diagnosed as nonobstructive hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm.
•Patients with heart function of New York Heart Association ≥ class II.
•Presenting with severe symptoms, e.g. angina, dyspnea, or fatigue, that were unresponsive or intolerant to pharmaceutical therapies;
•Kansas City Cardiomyopathy Questionnaire (KCCQ) score \< 80;
•Presenting with one of the following conditions: midventricular obstruction with gradient ≥ 50 mmHg; grade II or higher diastolic dysfunction; apical aneurysm; ventricular tachycardia that needed an ICD implantation; pulmonary hypertension.
•Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form.

Exclusion Criteria

•Patients who were pregnant.
•Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery.
•Patients who had severe heart failure with left ventricle ejection fraction \< 50%.
•Patients whose estimated life expectancy \< 12 months.
•Patient who were non-compliant.
•peak VO2 of cardiopulmonary exercise test ≥ 90% of predicted.
•LVOT obstruction.
•Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.

Outcomes

Primary Outcomes

Procedural success

Time Frame: 6 months

Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement of ≥10 points, New York Heart Association (NYHA) improvement ≥ 1 grade, stroke volume increased by ≥10 mL, and diastolic function grading at normal or grade I (of III) .