Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: Safety and Efficacy Results of a Phase I First-in-man Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, single-center, first-in-man study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: f
View:
• Patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmHg, and maximal ventricular septal wall thickness ≥ 15 mm.
• Patients with heart function of New York Heart Association ≥ class II.
• Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
• 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.
Locations
Other Locations
China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Xiang Wei, M.D.
xiangwei@tjh.tjmu.edu.cn
+8613995525956
Backup
Jing Fang, M.D.
jingfang@hust.edu.cn
+8613296640596
Time Frame
Start Date: 2022-04-15
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 1000
Treatments
Experimental: Hypertrophic Obstructive Cardiomyopathy
Transapical beating-heart septal myectomy for the patient with hypertrophic obstructive cardiomyopathy.
Related Therapeutic Areas
Sponsors
Leads: Xiang Wei