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Clinical Trials/NCT05648825
NCT05648825Active, not recruitingNot Applicable

Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy

Xiang Wei1 site in 1 country100 target enrollmentStarted: November 15, 2022Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Procedural success
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Transapical beating-heart septal myectomy

Experimental

Transapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy

Intervention: Transapical beating-heart septal myectomy (Device)

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) .

Secondary Outcomes

  • Left ventricular end-diastolic pressure(1 day)
  • Pulmonary artery wedge pressure(3 days)
  • Stroke volume(3 days)
  • NT-proBNP(N-terminal pro-brain natriuretic peptide)
  • cTnI(1 week, 6 months)
  • Angina level(6 months)
  • Left ventricular end-diastolic pressure(1 day)
  • Left ventricular end-systolic volume(7 days and 6 months)
  • Left ventricular end-diastolic volume(7 days and 6 months)
  • Obliteration(6 months)
  • Peak oxygen consumption(6 months)
  • pVO2(6 months)
  • Pulmonary artery wedge pressure(3 days)
  • Stroke volume(3 days)
  • Left ventricle mass(6 months)
  • Cardiac diastolic function(6 months)
  • Left atria volume(6 months)
  • Ventricular wall thickness(6 months)
  • LVOT gradient(1 week, 6 months)
  • Midventricular gradient(1 week, 6 months)
  • Device success(6 months)
  • New York Heart Association class(6 months)
  • 6-minute walking test(6 months)
  • Heart function-associated quality of life(6 months)
  • Major adverse cardiovascular and cerebral events(6 months)
  • All cause mortality(6 months)

Investigators

Sponsor
Xiang Wei
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Xiang Wei

Division of Cardiothoracic and Vascular Surgery

Tongji Hospital

Study Sites (1)

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