Hypertrophic Cardiomyopathy Clinical Trial
— AMARONEOfficial title:
Surgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
Verified date | September 2021 |
Source | St. Antonius Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 1, 2026 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | St. Antonius Hospital | Nieuwegein | Utrecht |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital | Erasmus Medical Center |
Netherlands,
Arslan F, Akdim F, Ten Berg JM. Reverse remodeling after percutaneous transluminal septal myocardial ablation in severe but asymptomatic LVOT obstruction (RASTA) study: Rationale and design of transcatheter septal reduction in asymptomatic patients with severe hypertrophic obstructive cardiomyopathy. Catheter Cardiovasc Interv. 2021 Feb 15;97(3):488-492. doi: 10.1002/ccd.29178. Epub 2020 Aug 18. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of participants with all-cause mortality | Follow up will be 1,3 and 5 years | ||
Secondary | Number of participants with cardiovascular mortality | Follow up will be 1,3 and 5 years | ||
Secondary | Number of participants with transient Ischemic Attack | Follow up will be 1,3 and 5 years | ||
Secondary | Number of participants with hospital Readmittance | Follow up will be 1,3 and 5 years | ||
Secondary | Number of participants with with occurrence of atrial fibrillation | Follow up will be 1,3 and 5 years | ||
Secondary | Number of participants with ventricular arrhythmias | Follow up will be 1,3 and 5 years | ||
Secondary | Number of participants with with complete heart block requiring permanent pacemaker implantation | Follow up will be 1,3 and 5 years | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | Blood sample results | Troponin T (in ug/l) | Follow up will be 1,3 and 5 years | |
Secondary | 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 | |
Secondary | Blood sample results | Creatine-kinase (CK in U/l) | Follow up will be 1,3 and 5 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Transthoracic echocardiogram | Left ventricle ejection fraction (%) | Follow up will be 1,3 and 5 years | |
Secondary | Transthoracic echocardiogram | Left ventricle outflow tract gradient (mmHg) | Follow up will be 1,3 and 5 years | |
Secondary | Transthoracic echocardiogram | Left ventricular internal systolic and diastolic dimension (cm) | Follow up will be 1,3 and 5 years | |
Secondary | Transthoracic echocardiogram | Atrial diameter (ml/m2) | Follow up will be 1,3 and 5 years | |
Secondary | Transthoracic echocardiogram | Valvular function | Follow up will be 1,3 and 5 years | |
Secondary | Transthoracic echocardiogram | Right ventricular systolic pressure (mmHg) | Follow up will be 1,3 and 5 years | |
Secondary | Transthoracic echocardiogram | Interventricular septal thickness (mm) | Follow up will be 1,3 and 5 years |
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