Surgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertrophic Cardiomyopathy
- Sponsor
- St. Antonius Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of this randomized trial is to compare the improvement in exercise capacity among patients with highly symptomatic hypertrophic obstructive cardiomyopathy despite optimal medical treatment who undergo alcohol septal ablation (ASA) or surgical septal myectomy (SSM).
Detailed Description
This is a prospective, multicentre, open label, randomized controlled, non-inferiority trial (RCT) with a 1:1 randomization to alcohol septal ablation or surgical septal myectomy in patients with hypertrophic obstructive cardiomyopathy (HOCM) between 40-75 year of age with symptoms and/or syncope due to HOCM despite medical therapy. A total of 100 patients will be included. All patients will be evaluated with bicycle ergometry exercise test, MRI and 2D-echo before and 1 year after invasive treatment. Follow-up will be at 1,3 and 5 years.
Investigators
J.M. ten Berg
Clinical Professor
St. Antonius Hospital
Eligibility Criteria
Inclusion Criteria
- •Age between 40-75 years including 40 and 75 years of age
- •HOCM eligible for both SSM and ASA by a heart team (multidisciplinary team) and core lab.
- •Left ventricle outflow tract (LVOT) obstruction \> 30mmHg at rest or during physiological provocation by transthoracic echocardiogram
- •Symptomatic (New York Heart Association classification (NYHA) \>1 or Canadian Cardiovascular Society (CCS) class \>1) and/or syncope due to HOCM
Exclusion Criteria
- •Unable to give informed consent
- •A life expectancy of less than 1 year
- •Concomitant (structural valve disease, aorta, rhythm, CABG) surgery during the same session
- •Not able to perform bicycle ergometry exercise test
Outcomes
Primary Outcomes
Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test
Time Frame: 1 year after the invasive treatment
The primary endpoint is the improvement of the exercise capacity in the form of Metabolic Equivalent (METs) which will be assessed with a bicycle ergometry exercise test (difference in exercise capacity in Metabolic Equivalents) performed before and 1 year after invasive treatment.
Secondary Outcomes
- Number of participants with hospital Readmittance(Follow up will be 1,3 and 5 years)
- Number of participants with with complete heart block requiring permanent pacemaker implantation(Follow up will be 1,3 and 5 years)
- Number of participants with re-intervention(Follow up will be 1,3 and 5 years)
- Number of participants with cardiovascular mortality(Follow up will be 1,3 and 5 years)
- Number of participants with ventricular arrhythmias(Follow up will be 1,3 and 5 years)
- Number of participants with all-cause mortality(Follow up will be 1,3 and 5 years)
- Quality of life evaluation using the The Kansas City Cardiomyopathy Questionnaire (KCCQ)(Follow up will be 1,3 and 5 years)
- Transthoracic echocardiogram(Follow up will be 1,3 and 5 years)
- Number of participants with transient Ischemic Attack(Follow up will be 1,3 and 5 years)
- Number of participants with with occurrence of atrial fibrillation(Follow up will be 1,3 and 5 years)
- Number of participants with major bleeding(First 30 days)
- Blood sample results(Follow up will be 1,3 and 5 years)
- Cardiac Magnetic Resonance Imaging (CMR) parameters(Follow up will be 1,3 and 5 years)