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NCT Number: NCT05648825

Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Nonobstructive Hypertrophic Cardiomyopathy

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transapical beating-heart septal myectomy

Device

We have invented a beating-heart myectomy device. Using this device, myectomy could be performed in the beating heart via a mini-thoractomy approach. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. We are now conducting the study to explore the feasibility, the safety, and the efficacy of transapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy.

Primary outcomes

  1. 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

  1. Left ventricular end-diastolic pressure

    Time frame: 1 day

    Left ventricular end-diastolic pressure measure by hemodynamic catheterization.

  2. Left ventricular end-systolic volume

    Time frame: 7 days and 6 months

    Left ventricular end-systolic volume and indexed by body surface area. A higher left ventricular end-systolic volume indicates enlarged left ventricular chamber.

  3. Left ventricular end-diastolic volume

    Time frame: 7 days and 6 months

    Left ventricular end-diastolic volume and indexed by body surface area. A higher left ventricular end-diastolic volume indicates enlarged left ventricular chamber.

  4. Obliteration

    Time frame: 6 months

    Rate of obliteration and ratio of obliteration to cavity as measured by TTE

  5. Peak oxygen consumption

    Time frame: 6 months

    Peak oxygen consumption as measured by cardiopulmonary exercise testing.

  6. pVO2

    Time frame: 6 months

    pVO2 as measured by cardiopulmonary exercise testing.

  7. Pulmonary artery wedge pressure

    Time frame: 3 days

    Pulmonary artery wedge pressure as measured by Swan-Ganz catheter.

  8. Stroke volume

    Time frame: 3 days

    Stroke volume as measured by Swan-Ganz catheter.

  9. Left ventricle mass

    Time frame: 6 months

    Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.

  10. Cardiac diastolic function

    Time frame: 6 months

    The ratio between early mitral inflow velocity and mitral annular early diastolic velocity ( E/e') and ratio between early mitral inflow velocity and late mitral inflow velocity (E/A) as measured by transthoracic echocardiography.

  11. Left atria volume

    Time frame: 6 months

    The left atria volume as measured by echocardiography.

  12. Ventricular wall thickness

    Time frame: 6 months

    Ventricular wall thickness as measured by echocardiography.

  13. LVOT gradient

    Time frame: 1 week, 6 months

    Resting and provoked left ventricular outflow tract gradient as measured by echocardiography.

  14. Midventricular gradient

    Time frame: 1 week, 6 months

    Resting and provoked midventricular gradient as measured by echocardiography.

  15. Device success

    Time frame: 6 months

    Successful accession, delivery, and retrieval of the resection device, successful resection of the ventricular myocardium, and free from conversion to midline thoracotomy during operation.

  16. New York Heart Association class

    Time frame: 6 months

    New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function.

  17. 6-minute walking test

    Time frame: 6 months

    6-minute walking test. A longer distance means better heart function.

  18. Heart function-associated quality of life

    Time frame: 6 months

    Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function.

  19. Angina level

    Time frame: 6 months

    Score of the Seattle angina questionnaire.

  20. NT-proBNP

    Time frame: N-terminal pro-brain natriuretic peptide

  21. cTnI

    Time frame: 1 week, 6 months

    cardiac troponin I

  22. Major adverse cardiovascular and cerebral events

    Time frame: 6 months

    Procedure-related mortality and unplanned surgical procedures during hospitalization, permanent pacemaker implantation, iatrogenic valvular injury, imaging examination-validated cerebral complications.

  23. All cause mortality

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Xiang Wei

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 13, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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