Obstructive Hypertrophic Cardiomyopathy
Conditions
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.
Interventions
PROCEDUREPercutaneous Endocardial Septal Radiofrequency Ablation
Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 NT-proBNP | 6 months,9 months and 12 months | Cardiac biomarker |
| 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 Left ventricular ejection fraction (LVEF) | 6 months,9 months and 12 months | LVEF 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 Left atrial diameter (LAD) | 6 months,9 months and 12 months | LAD measured by echocardiography |
| Change in Maximal wall thickness (MWT) | 6 months,9 months and 12 months | MWT measured by echocardiography |
| Change in Left ventricular mass index (LVMi) | 6 months,9 months and 12 months | LVMi measured by cardiac magnetic resonance |
| Change in Late gadolinium enhancement (LGE) | 6 months,9 months and 12 months | LGE measured by cardiac magnetic resonance |
| Change in Cardiac index (CI) | 6 months,9 months and 12 months | CI measured by cardiac magnetic resonance |
| Change in Left ventricular end-diastolic diameter (LVEDD) | 6 months,9 months and 12 months | LVEDD measured by echocardiography |
Countries
China
Contacts
Primary ContactLingmin Wu
Outcome results
None listed