Status:
UNKNOWN
Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy
Lead Sponsor:
Second Xiangya Hospital of Central South University
Conditions:
Hypertrophic Obstructive Cardiomyopathy
Stereotactic Body Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is designed to rigorously evaluate the safety and effectiveness of Stereotactic Body Radiotherapy (SBRT) as an innovative, non-invasive treatment for Hypertrophic Obstructive Cardiomyopathy...
Eligibility Criteria
Inclusion
- Adults aged 18 years or older.
- Confirmed diagnosis of Hypertrophic Obstructive Cardiomyopathy (HOCM) with a left ventricular outflow tract resting pressure gradient of 50mmHg or greater, as evidenced by cardiac ultrasound or Cardiac MRI.
- Willingness and consent to undergo non-invasive cardiac radioablation technology for the treatment of HOCM.
- Provision of informed consent, indicating voluntary participation in the study.
- Capability to read, understand, and communicate in Chinese for study-related procedures and consent.
Exclusion
- Participation in any interventional clinical trial within 30 days prior to enrollment in this study, excluding participation in non-interventional and diagnostic reagent studies.
- Previous receipt of any invasive treatment options for HOCM.
- Advanced heart failure characterized by NYHA functional class IV.
- A left Ventricular Ejection Fraction (LVEF) of less than 30%.
- Concurrent severe illnesses that are life-limiting with an expected lifespan of less than one year.
- Planned or requirement for any form of surgical intervention.
- Pregnancy or currently breastfeeding.
- Involvement in the execution or implementation of this study, including study staff and their immediate family members.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06167876
Start Date
December 15 2023
End Date
June 15 2025
Last Update
December 19 2023
Active Locations (4)
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1
Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University
Changsha, Hunan, China, 410005
2
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
3
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421001
4
Xiangtan Central Hospital
Xiangtan, Hunan, China, 411413