Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy
NCT ID: NCT06391788
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
132 participants
INTERVENTIONAL
2023-03-31
2025-03-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thoracoscopic trans-mitral myectomy
patients who undergo thoracoscopic Morrow procedure
thoracoscopic Morrow surgery
minimally invasive trans-mitral Morrow septal myectomy
Modified extended Morrow myectomy
patients who undergo modified extended Morrow myectomy
modified Morrow surgery
median open modified enlarged Morrow septal myectomy
Interventions
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thoracoscopic Morrow surgery
minimally invasive trans-mitral Morrow septal myectomy
modified Morrow surgery
median open modified enlarged Morrow septal myectomy
Eligibility Criteria
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Inclusion Criteria
* age ≥18 years old;
* presence of left ventricular outflow tract/mid-ventricular obstruction, with a resting left ventricular outflow tract pressure gradient/left ventricular cavity pressure gradient ≥50 mmHg; significant symptoms persist despite optimal medical therapy, and surgical evaluation indicates the need for intervention;
* left ventricular ejection fraction (LVEF) ≥55%;
* signed informed consent, willing and able to return to the hospital for follow-up.
Exclusion Criteria
* received or planning to receive an implantable cardioverter-defibrillator (ICD) in the past 3 months;
* individuals with concomitant conditions requiring simultaneous surgical intervention;
* New York Heart Association (NYHA) functional class IV;
* unwilling to undergo surgical treatment;
* pregnant or lactating or planning pregnancy;
* previously participated in other clinical trials before enrollment;
* individuals with concurrent diseases with an expected lifespan of less than 1 year.
18 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Xin Wang
Role: PRINCIPAL_INVESTIGATOR
Fuwai Hospital, National Centre for Cardiovascular Disease
Lei Song
Role: PRINCIPAL_INVESTIGATOR
Fuwai Hospital, National Centre for Cardiovascular Disease
Locations
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Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Xin Wang
Role: primary
Lei Song
Role: backup
Other Identifiers
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2023-ZX013
Identifier Type: -
Identifier Source: org_study_id