Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy

Percutaneous Endocardial Septal Radiofrequency Ablation in the Treatment of Obstructive Hypertrophic Cardiomyopathy: a Prospective, Multicenter, Single-arm Objective Performance Criteria Trial

This study is testing a new procedure called radiofrequency ablation to see if it can help people with obstructive hypertrophic cardiomyopathy breathe easier and feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (other gov)
• Locations: 1 site (Beijing)
• Trial ID: NCT06224621 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in patients with obstructive hypertrophic cardiomyopathy (oHCM). It is a multicenter, single-arm trial that aims to assess the impact of PESA on patients experiencing left ventricular outflow tract obstruction or midventricular obstruction. The study will measure treatment outcomes, including functional capacity, quality of life, and long-term prognosis for participants. Patients will be monitored for their response to the procedure and overall health improvements.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with hypertrophic cardiomyopathy who have significant left ventricular outflow tract or midventricular obstruction despite optimal medical therapy.

Not a fit: Patients with isolated papillary muscle hypertrophy or those who have previously undergone septal reduction therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and functional capacity for patients with obstructive hypertrophic cardiomyopathy.

How similar studies have performed: While this approach is being evaluated in this trial, similar interventions have shown promise in treating obstructive hypertrophic cardiomyopathy, suggesting potential for success.

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.

Where this trial is running

Beijing

• Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Lingmin Wu

Conditions: Obstructive Hypertrophic Cardiomyopathy