Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-04
Brief Title:
Echocardiography-guided Percutaneous Septal Radiofrequency Ablation for Obstructive HCM After Alcohol Septal Ablation
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Efficacy and Safety of Echocardiography-guided Percutaneous Intraventricular Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy After Alcohol Septal Ablation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCM
Brief Summary:
After alcohol ablation some HOCM patients have serious clinical symptoms and adverse complications and need to undergo invasive surgery again when adequate drug therapy is not effective or cannot tolerate the side effects of drugs Liwen surgery is a safe and effective new minimally invasive treatment for HOCM patients so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery in HOCM patients who failed alcohol ablation and provide new treatment methods for patients
Detailed Description:
Hypertrophic cardiomyopathy HCM is the most common inherited cardiovascular disease mostly due to mutations in the gene encoding myocardial sarcomere contractile protein with an incidence of about 1500-1200 HCM is the main cause of sudden cardiac death in young people and athletes Its clinical manifestations are highly heterogeneous Some patients have no obvious symptoms or mild symptoms but some patients have obvious myocardial hypertrophy in the early stage resulting in chest tightness chest pain breathing difficulties syncope heart failure and even sudden cardiac death The annual mortality rate of HCM patients is about 14 -22 Alcohol septal ablation ASA is a kind of interventional therapy Its principle is to inject anhydrous alcohol through a catheter occlude the septal branch of the coronary artery make the hypertrophic ventricular septal myocardium that dominates it ischemic necrosis thinning and contractility decrease so that the obstruction of the outflow tract disappears or alleviates thereby improving the clinical symptoms of patients However HOCM patients often have serious clinical symptoms and adverse complications after alcohol ablation and invasive surgical treatment is required when adequate drug therapy is not effective or cannot tolerate the side effects of drugs Liwen surgery is a safe and effective new path to treat minimally invasive HOCM patients so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery after alcohol ablation in HOCM patients and to verify its early postoperative efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None