Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy

Study 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.

Official Title
-----------------
Surgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy

Conditions
-----------------
Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Procedure: Alcohol Septal Ablation
* Procedure: Surgical Septal Myectomy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alcohol Septal Ablation<br> | Procedure: Alcohol Septal Ablation<br>* Participants will be treated with alcohol septal ablation.<br>|
| Active Comparator: Surgical Septal Myectomy<br> | Procedure: Surgical Septal Myectomy<br>* Participants will be treated with surgical septal myectomy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test | 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. | 1 year after the invasive treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with all-cause mortality |  | 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 transient Ischemic Attack |  | Follow up will be 1,3 and 5 years | 
| Number of participants with hospital Readmittance |  | 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 ventricular arrhythmias |  | 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 major bleeding | Bleeding rate will be analysed using Bleeding Academic Research Consortium (type 3,4 or 5), TIMI major and VARC major criteria. | First 30 days | 
| Number of participants with re-intervention | One more time need for Alcohol septal ablation or surgical septal myectomy | Follow up will be 1,3 and 5 years | 
| Blood sample results | Troponin T (in ug/l) | Follow up will be 1,3 and 5 years | 
| Blood sample results | N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP in pg/ml) | Follow up will be 1,3 and 5 years | 
| Blood sample results | Creatine-kinase (CK in U/l) | Follow up will be 1,3 and 5 years | 
| Quality of life evaluation using the The Kansas City Cardiomyopathy Questionnaire (KCCQ) | In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. For brevity, only the performance characteristics of the overall summary score are presented in this discussion. | Follow up will be 1,3 and 5 years | 
| Cardiac Magnetic Resonance Imaging (CMR) parameters | Interventricular septal thickness (mm), atrial diameter (mm) , left and right ventricular diameter (mm), left ventricle end diastolic volume (ml), left ventricle systolic volume (ml) | Follow up will be 1,3 and 5 years | 
| Cardiac Magnetic Resonance Imaging (CMR) parameters | Left ventricle end diastolic volume (ml), left ventricle systolic volume (ml) | Follow up will be 1,3 and 5 years | 
| Transthoracic echocardiogram | Left ventricle ejection fraction (%) | Follow up will be 1,3 and 5 years | 
| Transthoracic echocardiogram | Left ventricle outflow tract gradient (mmHg) | Follow up will be 1,3 and 5 years | 
| Transthoracic echocardiogram | Left ventricular internal systolic and diastolic dimension (cm) | Follow up will be 1,3 and 5 years | 
| Transthoracic echocardiogram | Atrial diameter (ml/m2) | Follow up will be 1,3 and 5 years | 
| Transthoracic echocardiogram | Valvular function | Follow up will be 1,3 and 5 years | 
| Transthoracic echocardiogram | Right ventricular systolic pressure (mmHg) | Follow up will be 1,3 and 5 years | 
| Transthoracic echocardiogram | Interventricular septal thickness (mm) | Follow up will be 1,3 and 5 years |