Clinical trial NCT04684290: Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
Official title: Surgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2020-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test
timeFrame: 1 year after the invasive treatment
Secondary outcomes:
measure: Number of participants with all-cause mortality
timeFrame: Follow up will be 1,3 and 5 years
measure: Number of participants with cardiovascular mortality
timeFrame: Follow up will be 1,3 and 5 years
measure: Number of participants with transient Ischemic Attack
timeFrame: Follow up will be 1,3 and 5 years
measure: Number of participants with hospital Readmittance
timeFrame: Follow up will be 1,3 and 5 years
measure: Number of participants with with occurrence of atrial fibrillation
timeFrame: Follow up will be 1,3 and 5 years
measure: Number of participants with ventricular arrhythmias
timeFrame: Follow up will be 1,3 and 5 years
measure: Number of participants with with complete heart block requiring permanent pacemaker implantation
timeFrame: Follow up will be 1,3 and 5 years
measure: Number of participants with major bleeding
timeFrame: First 30 days
measure: Number of participants with re-intervention
timeFrame: Follow up will be 1,3 and 5 years
measure: Blood sample results
timeFrame: Follow up will be 1,3 and 5 years
measure: Blood sample results
timeFrame: Follow up will be 1,3 and 5 years
measure: Blood sample results
timeFrame: Follow up will be 1,3 and 5 years
measure: Quality of life evaluation using the The Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Follow up will be 1,3 and 5 years
measure: Cardiac Magnetic Resonance Imaging (CMR) parameters
timeFrame: Follow up will be 1,3 and 5 years
measure: Cardiac Magnetic Resonance Imaging (CMR) parameters
timeFrame: Follow up will be 1,3 and 5 years
measure: Transthoracic echocardiogram
timeFrame: Follow up will be 1,3 and 5 years
measure: Transthoracic echocardiogram
timeFrame: Follow up will be 1,3 and 5 years
measure: Transthoracic echocardiogram
timeFrame: Follow up will be 1,3 and 5 years
measure: Transthoracic echocardiogram
timeFrame: Follow up will be 1,3 and 5 years
measure: Transthoracic echocardiogram
timeFrame: Follow up will be 1,3 and 5 years
measure: Transthoracic echocardiogram
timeFrame: Follow up will be 1,3 and 5 years
measure: Transthoracic echocardiogram
timeFrame: Follow up will be 1,3 and 5 years
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
Study officials:
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