Comparing two treatments for hypertrophic obstructive cardiomyopathy
Surgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
This study is testing whether a procedure called alcohol septal ablation works as well as surgery for improving exercise ability in people with a heart condition called hypertrophic obstructive cardiomyopathy who still have symptoms despite taking their medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 1 site (Nieuwegein, Utrecht) |
| Trial ID | NCT04684290 on ClinicalTrials.gov |
What this trial studies
This randomized trial aims to evaluate the effectiveness of alcohol septal ablation versus surgical septal myectomy in improving exercise capacity for patients suffering from symptomatic hypertrophic obstructive cardiomyopathy despite optimal medical treatment. The study will involve 100 patients aged 40 to 75, who will be randomly assigned to one of the two treatment groups. Participants will undergo assessments including bicycle ergometry exercise tests, MRI, and 2D echocardiography before and one year after the intervention, with follow-up evaluations at 1, 3, and 5 years. The trial is designed as a multicenter, open-label, randomized controlled trial to determine the non-inferiority of the two approaches.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-75 with symptomatic hypertrophic obstructive cardiomyopathy and significant left ventricle outflow tract obstruction despite medical therapy.
Not a fit: Patients with a life expectancy of less than one year or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a clearer understanding of the most effective treatment option for their condition, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown promising results in comparing these two treatment modalities, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 40-75 years including 40 and 75 years of age 2. HOCM eligible for both SSM and ASA by a heart team (multidisciplinary team) and core lab. 3. Left ventricle outflow tract (LVOT) obstruction \> 30mmHg at rest or during physiological provocation by transthoracic echocardiogram 4. Symptomatic (New York Heart Association classification (NYHA) \>1 or Canadian Cardiovascular Society (CCS) class \>1) and/or syncope due to HOCM Exclusion Criteria: 1. Unable to give informed consent 2. A life expectancy of less than 1 year 3. Concomitant (structural valve disease, aorta, rhythm, CABG) surgery during the same session 4. Not able to perform bicycle ergometry exercise test
Where this trial is running
Nieuwegein, Utrecht
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.