Clinical trial NCT06224621: Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy
Official title: Percutaneous Endocardial Septal Radiofrequency Ablation in the Treatment of Obstructive Hypertrophic Cardiomyopathy: a Prospective, Multicenter, Single-arm Objective Performance Criteria Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-01-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in LVOT gradiant/midventricular gradient
timeFrame: 6 months,9 months and 12 months
Secondary outcomes:
measure: Change in 6 minute walking test
timeFrame: 6 months,9 months and 12 months
measure: Change in NYHA cardiac function class
timeFrame: 6 months,9 months and 12 months
measure: Change in cTnT
timeFrame: 6 months,9 months and 12 months
measure: Change in cTnI
timeFrame: 6 months,9 months and 12 months
measure: Change in NT-proBNP
timeFrame: 6 months,9 months and 12 months
measure: Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score
timeFrame: 6 months,9 months and 12 months
measure: Change in Left ventricular ejection fraction (LVEF)
timeFrame: 6 months,9 months and 12 months
measure: Change in Left ventricular end-diastolic diameter (LVEDD)
timeFrame: 6 months,9 months and 12 months
measure: Change in Left atrial diameter (LAD)
timeFrame: 6 months,9 months and 12 months
measure: Change in Maximal wall thickness (MWT)
timeFrame: 6 months,9 months and 12 months
measure: Change in Left ventricular mass index (LVMi)
timeFrame: 6 months,9 months and 12 months
measure: Change in Late gadolinium enhancement (LGE)
timeFrame: 6 months,9 months and 12 months
measure: Change in Cardiac index (CI)
timeFrame: 6 months,9 months and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
References: