Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391788
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-15
Brief Title:
Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
China National Center for Cardiovascular Diseases
Study Overview
Official Title:
Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy a Single-center Prospective Open-label Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
This single-center prospective open-label randomized controlled clinical trial is designed to assess the efficacy and safety of the Thoracoscopic Morrow procedure in the treatment of hypertrophic obstructive cardiomyopathy The primary objectives include investigating
Question 1 The efficacy and safety of two surgical modalities in patients presenting with left ventricular outflow tract obstruction and mid-left ventricular hypertrophy
Question 2 The impact of the two surgical procedures on hemodynamics in patients with left ventricular outflow tract obstruction mid-left ventricular obstruction and in individuals with or without organic valvular lesions
Question 3 The effects of the two surgical procedures on exercise capacity quality of life and long-term prognosis among patients with left ventricular outflow tract obstruction and central left ventricular obstruction both with and without valvular lesions
Participants will be stratified into two groups The experimental group will undergo thoracoscopic Morrow surgery while the control group will undergo median open modified enlarged Morrow surgery
Question 1 The efficacy and safety of two surgical modalities in patients presenting with left ventricular outflow tract obstruction and mid-left ventricular hypertrophy
Question 2 The impact of the two surgical procedures on hemodynamics in patients with left ventricular outflow tract obstruction mid-left ventricular obstruction and in individuals with or without organic valvular lesions
Question 3 The effects of the two surgical procedures on exercise capacity quality of life and long-term prognosis among patients with left ventricular outflow tract obstruction and central left ventricular obstruction both with and without valvular lesions
Participants will be stratified into two groups The experimental group will undergo thoracoscopic Morrow surgery while the control group will undergo median open modified enlarged Morrow surgery
Detailed Description:
This study is a single-center prospective open-label randomized controlled trial designed to investigate the therapeutic value of thoracoscopic Morrow procedure in patients with hypertrophic obstructive cardiomyopathy HOCM The study focuses on HOCM patients with the modified extended Morrow procedure via median sternotomy considered as the gold standard treatment in the control group The objective is to explore the efficacy of the thoracoscopic Morrow procedure in improving exercise tolerance in HOCM patients assess the short-term and long-term effectiveness safety as well as changes in cardiac function cardiac structure and myocardial fibrosis levels associated with thoracoscopic Morrow procedure in treating obstructive HOCM
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