Status:
UNKNOWN
The Safety and Influencing Factors of Liwen Procedure in The Treatment of Hypertrophic Cardiomyopathy
Lead Sponsor:
Xijing Hospital
Conditions:
Hypertrophic Obstructive Cardiomyopathy
Eligibility:
All Genders
18-80 years
Brief Summary
Liwen procedure is generally safe and effective in treating hypertrophic cardiomyopathy, but a small proportion of patients have complications after the operation. The goal of this observational stud...
Eligibility Criteria
Inclusion
- Subject with symptoms that limit daily activities (New York Heart Association functional class \>II, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated
- Subject with a peak LVOT gradient≥50 mm Hg
- Subject volunteers for the Liwen procedure and received the procedure at the Hypertrophic Cardiomyopathy Center of Xijing Hospital.
Exclusion
- Subject with a peak instantaneous Doppler LVOT gradient of \<50 mm Hg
- Subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
- Subject has end-stage heart failure
Key Trial Info
Start Date :
July 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2024
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT06003478
Start Date
July 21 2023
End Date
May 30 2024
Last Update
August 22 2023
Active Locations (1)
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1
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032