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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06224621
Other study ID # 2023-ZX012
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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