Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy

NCT06391788 | Recruiting

• 1 other identifier: 2023-ZX013
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy, Hypertrophic Obstructive; Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• Left ventricular outflow tract gradient variability

  Change in Left ventricular outflow tract gradient pre- and post- intervention

  6 months,9 months and 12 months

Secondary Outcomes (6)

• 6-minute walk distance

  6 months,9 months and 12 months

• New York Heart Association Functional Classification of Heart Failure

  6 months,9 months and 12 months

• Marker of myocardial injury

  6 months,9 months and 12 months

• Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score

  6 months,9 months and 12 months

• Echocardiographic indicator

  6 months,9 months and 12 months

Study Arms (2)

Thoracoscopic trans-mitral myectomy

EXPERIMENTAL

patients who undergo thoracoscopic Morrow procedure

Procedure: thoracoscopic Morrow surgery

Modified extended Morrow myectomy

ACTIVE COMPARATOR

patients who undergo modified extended Morrow myectomy

Procedure: modified Morrow surgery

Interventions

thoracoscopic Morrow surgery PROCEDURE

minimally invasive trans-mitral Morrow septal myectomy

Thoracoscopic trans-mitral myectomy

modified Morrow surgery PROCEDURE

median open modified enlarged Morrow septal myectomy

Modified extended Morrow myectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with hypertrophic cardiomyopathy (HCM);
• 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.

You may not qualify if:

• previously underwent septal reduction therapy (including surgical or interventional procedures);
• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Xin Wang

  Fuwai Hospital, National Centre for Cardiovascular Disease

  PRINCIPAL INVESTIGATOR

• Lei Song

  Fuwai Hospital, National Centre for Cardiovascular Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Wang

CONTACT

13901036490; fuwaiwangxin@188.com

Lei Song

CONTACT

13810532620; songlqd@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 30, 2024
• Study Start: March 31, 2023
• Primary Completion: February 1, 2025
• Study Completion: March 31, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)