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Transapical Beating-heart Myectomy for the Treatment of Apical Hypertrophic Cardiomyopathy

Recruiting
12 years of age
Both
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Patients who were diagnosed as apical hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm.
  2. Patients with heart function of New York Heart Association ≥ class II.
  3. Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
  4. 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:

  1. Patients who were pregnant.
  2. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery.
  3. Patients who had severe heart failure with left ventricle ejection fraction < 40%.
  4. Patients whose estimated life expectancy < 12 months.
  5. Patient who were non-compliant.
  6. 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.

Study details

Apical Hypertrophic Cardiomyopathy

NCT05648825

Xiang Wei

8 March 2024

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