The Safety and Influencing Factors of Ultrasound-guided Percutaneous Intramyocardial Septal Radiofrequency Ablation (Liwen Procedure) in The Treatment of Hypertrophic Cardiomyopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 486
- Locations
- 1
- Primary Endpoint
- Postoperative Complications During Hospitalization
Study Overview
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 study is to explore the incidence of postoperative complications of the Liwen procedure in hypertrophic cardiomyopathy patients underwent Liwen procedure in Xijing Hospital. The main question it aims to answer are:
- What is the incidence of complications in HCM patients underwent Liwen Procedure during postoperative hospitalization and a short-term follow-up period?
- What is the relevant factors of complications in HCM patients who underwent Liwen Procedure during postoperative hospitalization and short-term follow-up period? Can the complications of surgical patients during postoperative hospitalization be predicted? Participants have been evaluated using a variety of medical examinations before they underwent Liwen Procedure. Variants collected from medical examination and case history were used to analyze the association with each postoperative complication.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Postoperative Complications During Hospitalization
Time Frame: From date of procedure until the date of first documented occurrence of symptomatic hypotension, or date of dischargement from hospital, assessed up to 1 month.
Complications including symptomatic postoperative hypotension observed during hospitalization after PIMSRA. The symptomatic postoperative hypotension is defined as systolic blood pressure lower than 90 mmHg documented by invasive or noninvasive blood pressure measurement accompanied by symptoms including dizziness, and cephalalgia, without regard to the duration of hypotension.
Secondary Outcomes
- Postoperative Complications During Follow-up Period(From date of dischargement until the date of first diagnosis of chronic hypotension or orthostatic hypotension, assessed up to 1 year.)
Investigators
Liu Liwen
Director
Xijing Hospital