Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy

Not Applicable

Recruiting

• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Interventions: Procedure: Percutaneous Endocardial Septal Radiofrequency Ablation

• Registration Number: NCT06224621
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Study Start: 2024-01-31
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Percutaneous Endocardial Septal Radiofrequency Ablation	Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.

Primary Outcome Measures

Name	Time	Method
Change in LVOT gradiant/midventricular gradient	6 months,9 months and 12 months	Change in Left ventricular outflow tract gradient pre- and post- intervention

Secondary Outcome Measures

Name	Time	Method
Change in Maximal wall thickness (MWT)	6 months,9 months and 12 months	MWT measured by echocardiography
Change in 6 minute walking test	6 months,9 months and 12 months	Change in 6 minute walking distance pre- and post- intervention
Change in NYHA cardiac function class	6 months,9 months and 12 months	A system used to categorize the severity of heart failure based on the functional limitations of individuals.
Change in cTnT	6 months,9 months and 12 months	Cardiac biomarker
Change in cTnI	6 months,9 months and 12 months	Cardiac biomarker
Change in Left ventricular end-diastolic diameter (LVEDD)	6 months,9 months and 12 months	LVEDD measured by echocardiography
Change in Left atrial diameter (LAD)	6 months,9 months and 12 months	LAD measured by echocardiography
Change in Cardiac index (CI)	6 months,9 months and 12 months	CI measured by cardiac magnetic resonance
Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score	6 months,9 months and 12 months	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
Change in Late gadolinium enhancement (LGE)	6 months,9 months and 12 months	LGE measured by cardiac magnetic resonance
Change in NT-proBNP	6 months,9 months and 12 months	Cardiac biomarker
Change in Left ventricular ejection fraction (LVEF)	6 months,9 months and 12 months	LVEF measured by echocardiography
Change in Left ventricular mass index (LVMi)	6 months,9 months and 12 months	LVMi measured by cardiac magnetic resonance

Trial Locations

Locations (1)

Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China