Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy

Obstructive Hypertrophic Cardiomyopathy Clinical Trial

Official title:

Percutaneous Endocardial Septal Radiofrequency Ablation in the Treatment of Obstructive Hypertrophic Cardiomyopathy: a Prospective, Multicenter, Single-arm Objective Performance Criteria Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224621
• Other study ID #: 2023-ZX012
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: January 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Lingmin Wu
• Phone: 18810488351
• Email: wlmxt2008[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating: 1. the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction; 2. the impact of PESA treatment on the functional capacity, quality of life and long-term prognosis of oHCM patients with either LVOTO or midventricular obstruction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of hypertrophic cardiomyopathy;
• At least 18 years old;
• The presence of a resting or maximum provoked LVOT/midventricular gradient of =50 mmHg with symptoms, despite maximum tolerated medical therapy;
• Willing to receive PESA treatment;
• LVEF=55%;
• Signed and dated written informed consent and willing to return for clinical follow-up.

Exclusion Criteria:

• Midventricular obstruction rendered by isolated papillary muscle hypertrophy;
• Complete right bundle branch block;
• Acute decompensation heart failure with NYHA IV;
• Previous septal reduction therapy including surgical and interventional procedures;
• Combination of other diseases requiring surgical treatment (including but not limited to coronary artery bypass grafting and apical aneurysm);
• Contraindications of radiofrequency ablation procedure;
• Women who are pregnant or lactating, or who plan to become pregnant while in the trial;
• Currently enrolled in another investigational device or drug trial;
• Combining any other clinical condition with a life expectancy less than 1 year.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy
• Obstructive Hypertrophic Cardiomyopathy

Intervention

Procedure:
• Percutaneous Endocardial Septal Radiofrequency Ablation
Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.

Locations

Country	Name	City	State
China	Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LVOT gradiant/midventricular gradient	Change in Left ventricular outflow tract gradient pre- and post- intervention	6 months,9 months and 12 months
Secondary	Change in 6 minute walking test	Change in 6 minute walking distance pre- and post- intervention	6 months,9 months and 12 months
Secondary	Change in NYHA cardiac function class	A system used to categorize the severity of heart failure based on the functional limitations of individuals.	6 months,9 months and 12 months
Secondary	Change in cTnT	Cardiac biomarker	6 months,9 months and 12 months
Secondary	Change in cTnI	Cardiac biomarker	6 months,9 months and 12 months
Secondary	Change in NT-proBNP	Cardiac biomarker	6 months,9 months and 12 months
Secondary	Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score	The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a patient reported outcome instrument with minimum score = 0 and maximum score = 100 where higher score indicates better health status. There are no units to the score. The instrument utilizes a recall period of 2 weeks over which patients describe the frequency and severity of their symptoms, their physical and social limitations, and how they perceive their heart failure symptoms to affect their quality of life. quality of life	6 months,9 months and 12 months
Secondary	Change in Left ventricular ejection fraction (LVEF)	LVEF measured by echocardiography	6 months,9 months and 12 months
Secondary	Change in Left ventricular end-diastolic diameter (LVEDD)	LVEDD measured by echocardiography	6 months,9 months and 12 months
Secondary	Change in Left atrial diameter (LAD)	LAD measured by echocardiography	6 months,9 months and 12 months
Secondary	Change in Maximal wall thickness (MWT)	MWT measured by echocardiography	6 months,9 months and 12 months
Secondary	Change in Left ventricular mass index (LVMi)	LVMi measured by cardiac magnetic resonance	6 months,9 months and 12 months
Secondary	Change in Late gadolinium enhancement (LGE)	LGE measured by cardiac magnetic resonance	6 months,9 months and 12 months
Secondary	Change in Cardiac index (CI)	CI measured by cardiac magnetic resonance	6 months,9 months and 12 months