Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Jan 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) to treat patients with obstructive hypertrophic cardiomyopathy (oHCM). This condition can cause the heart to become thickened, making it harder for blood to flow. The trial aims to see how effective and safe the PESA treatment is, especially for those experiencing specific types of obstruction in the heart. Additionally, researchers want to find out how this treatment affects patients’ overall health, quality of life, and long-term outcomes.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with hypertrophic cardiomyopathy. They should also have certain symptoms and a specific level of heart obstruction, which hasn’t improved with medication alone. Participants need to be willing to undergo the PESA treatment and sign consent forms to take part in the study. Throughout the trial, participants can expect regular follow-ups to monitor their health and the effects of the treatment. It’s important to note that certain medical conditions or treatments may exclude someone from participating, so discussing eligibility with a healthcare provider is crucial.

Gender

ALL

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.