Clinical trial NCT05648825: Transapical Beating-heart Myectomy for the Treatment of Apical Hypertrophic Cardiomyopathy
Official title: Transapical Beating-heart Myectomy in Patient With Apical Hypertrophic Cardiomyopathy: Safety and Efficacy Results of a Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apical Hypertrophic Cardiomyopathy
Keywords: Apical Hypertrophic Cardiomyopathy
Septal Myectomy
Transapical Beating-heart Septal Myectomy
Minimally Invasive
Midventricular obstruction and cavity obliteration
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Beating-Heart Myectomy Device
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 3 months
measure: Procedural success
timeFrame: 3 months
Secondary outcomes:
measure: Left ventricular end-diastolic pressure
timeFrame: 1 day
measure: Left ventricular end-systolic volume
timeFrame: 7 days and 3 months
measure: Peak oxygen consumption
timeFrame: 3 months
measure: Pulmonary artery wedge pressure
timeFrame: 3 days
measure: Stroke volume
timeFrame: 3 days
measure: Left ventricle mass
timeFrame: 3 months
measure: Cardiac diastolic function
timeFrame: 3 months
measure: Left atria volume
timeFrame: 3 months
measure: Ventricular wall thickness
timeFrame: 3 months
measure: Device success
timeFrame: 3 months
measure: New York Heart Association class
timeFrame: 3 months
measure: 6-minute walking test
timeFrame: 3 months
measure: Heart function-associated quality of life
timeFrame: 3 months
measure: Major adverse cardiovascular and cerebral events
timeFrame: 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiang Wei, M.D.
role: STUDY_CHAIR
References:
citation: Fang J, Wang R, Liu H, Su Y, Chen J, Han X, Wei Y, Chen Y, Cheng L, Wei X. Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):303-311. doi: 10.1093/icvts/ivz249.
citation: Schaff HV, Brown ML, Dearani JA, Abel MD, Ommen SR, Sorajja P, Tajik AJ, Nishimura RA. Apical myectomy: a new surgical technique for management of severely symptomatic patients with apical hypertrophic cardiomyopathy. J Thorac Cardiovasc Surg. 2010 Mar;139(3):634-40. doi: 10.1016/j.jtcvs.2009.07.079.