The Safety and Influencing Factors of Liwen Procedure in The Treatment of Hypertrophic Cardiomyopathy

NCT06003478 | Unknown

• 1 other identifier: KY20232228-C-1
• Study Type: observational
• Target: 486
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

Cardiomyopathy, hypertrophic; Hypotension; Postoperative Complication

Outcome Measures

Primary Outcomes (1)

• Postoperative Complications During Hospitalization

  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.

  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.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Hypertrophic Obstructive Cardiomyopathy Patients

Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)

Interventions

Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure) PROCEDURE

Under transthoracic echocardiography (TTE) guidance, the puncture site is positioned at the apex. A guiding line is applied along the septal long axis and the radiofrequency ablation electrode needle(17G, Cool-tip™ RF Ablation System and Switching Controller;Medtronic, Minneapolis, MN, USA) pierced towards the hypertrophic anterior interventricular septum (AIVS) 8-10 mm from the subaortic valve. Each ablation lasts for up to 12 min and the ablation power is gradually increased from 30-40W. Then, the ablation needle is withdrawn 10 mm to prepare for the next application. Overall, 3-4 applications are performed in each patient. The ablation creates an area of thermal coagulative myocardial necrosis that appears as a hyperechogenic reflection detected by TTE. If deemed necessary, we repeat the procedure at the posterior interventricular septum (PIVS).

Hypertrophic Obstructive Cardiomyopathy Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with obstructive HCM and with drug-refractory symptoms underwent Liwen Procedure in Xijing Hospital from 2016 October to 2023 July.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Shan B, Li J, Shi Z, Han C, Zhang J, Zhao J, Hu R, Liu L, Ta S. Predictive value of estimated plasma volume for postoperative hypotension in percutaneous intramyocardial septal radiofrequency ablation treating for hypertrophic obstructive cardiomyopathy. BMC Cardiovasc Disord. 2024 Mar 22;24(1):177. doi: 10.1186/s12872-024-03844-9.

  PMID: 38519968 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Hypotension; Postoperative Complications

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 22, 2023
• Study Start: July 21, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

CN (1)