- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684290
Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy (AMARONE)
September 8, 2021 updated by: J.M. ten Berg, St. Antonius Hospital
Surgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utrecht
-
Nieuwegein, Utrecht, Netherlands, 3435CM
- Recruiting
- St. Antonius Hospital
-
Contact:
- Jurrien ten Berg
- Phone Number: 088 320 3000
- Email: j.ten.berg@antoniusziekenhuis.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Alcohol Septal Ablation
|
Participants will be treated with alcohol septal ablation.
|
Active Comparator: Surgical Septal Myectomy
|
Participants will be treated with surgical septal myectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year after the invasive treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with all-cause mortality
Time Frame: Follow up will be 1,3 and 5 years
|
Follow up will be 1,3 and 5 years
|
|
Number of participants with cardiovascular mortality
Time Frame: Follow up will be 1,3 and 5 years
|
Follow up will be 1,3 and 5 years
|
|
Number of participants with transient Ischemic Attack
Time Frame: Follow up will be 1,3 and 5 years
|
Follow up will be 1,3 and 5 years
|
|
Number of participants with hospital Readmittance
Time Frame: Follow up will be 1,3 and 5 years
|
Follow up will be 1,3 and 5 years
|
|
Number of participants with with occurrence of atrial fibrillation
Time Frame: Follow up will be 1,3 and 5 years
|
Follow up will be 1,3 and 5 years
|
|
Number of participants with ventricular arrhythmias
Time Frame: Follow up will be 1,3 and 5 years
|
Follow up will be 1,3 and 5 years
|
|
Number of participants with with complete heart block requiring permanent pacemaker implantation
Time Frame: Follow up will be 1,3 and 5 years
|
Follow up will be 1,3 and 5 years
|
|
Number of participants with major bleeding
Time Frame: First 30 days
|
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
Time Frame: Follow up will be 1,3 and 5 years
|
One more time need for Alcohol septal ablation or surgical septal myectomy
|
Follow up will be 1,3 and 5 years
|
Blood sample results
Time Frame: Follow up will be 1,3 and 5 years
|
Troponin T (in ug/l)
|
Follow up will be 1,3 and 5 years
|
Blood sample results
Time Frame: Follow up will be 1,3 and 5 years
|
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
Time Frame: Follow up will be 1,3 and 5 years
|
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)
Time Frame: Follow up will be 1,3 and 5 years
|
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
Time Frame: Follow up will be 1,3 and 5 years
|
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
Time Frame: Follow up will be 1,3 and 5 years
|
Left ventricle end diastolic volume (ml), left ventricle systolic volume (ml)
|
Follow up will be 1,3 and 5 years
|
Transthoracic echocardiogram
Time Frame: Follow up will be 1,3 and 5 years
|
Left ventricle ejection fraction (%)
|
Follow up will be 1,3 and 5 years
|
Transthoracic echocardiogram
Time Frame: Follow up will be 1,3 and 5 years
|
Left ventricle outflow tract gradient (mmHg)
|
Follow up will be 1,3 and 5 years
|
Transthoracic echocardiogram
Time Frame: Follow up will be 1,3 and 5 years
|
Left ventricular internal systolic and diastolic dimension (cm)
|
Follow up will be 1,3 and 5 years
|
Transthoracic echocardiogram
Time Frame: Follow up will be 1,3 and 5 years
|
Atrial diameter (ml/m2)
|
Follow up will be 1,3 and 5 years
|
Transthoracic echocardiogram
Time Frame: Follow up will be 1,3 and 5 years
|
Valvular function
|
Follow up will be 1,3 and 5 years
|
Transthoracic echocardiogram
Time Frame: Follow up will be 1,3 and 5 years
|
Right ventricular systolic pressure (mmHg)
|
Follow up will be 1,3 and 5 years
|
Transthoracic echocardiogram
Time Frame: Follow up will be 1,3 and 5 years
|
Interventricular septal thickness (mm)
|
Follow up will be 1,3 and 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Authors/Task Force members, Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
- Wigle ED. Cardiomyopathy: The diagnosis of hypertrophic cardiomyopathy. Heart. 2001 Dec;86(6):709-14. doi: 10.1136/heart.86.6.709. No abstract available.
- Sherrid MV, Wever-Pinzon O, Shah A, Chaudhry FA. Reflections of inflections in hypertrophic cardiomyopathy. J Am Coll Cardiol. 2009 Jul 14;54(3):212-9. doi: 10.1016/j.jacc.2009.03.052.
- Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 13;124(24):e783-831. doi: 10.1161/CIR.0b013e318223e2bd. Epub 2011 Nov 8. No abstract available.
- Veselka J, Faber L, Liebregts M, Cooper R, Januska J, Krejci J, Bartel T, Dabrowski M, Hansen PR, Almaas VM, Seggewiss H, Horstkotte D, Adlova R, Bundgaard H, Ten Berg J, Stables RH, Jensen MK. Outcome of Alcohol Septal Ablation in Mildly Symptomatic Patients With Hypertrophic Obstructive Cardiomyopathy: A Long-Term Follow-Up Study Based on the Euro-Alcohol Septal Ablation Registry. J Am Heart Assoc. 2017 May 16;6(5):e005735. doi: 10.1161/JAHA.117.005735.
- Jensen MK, Faber L, Liebregts M, Januska J, Krejci J, Bartel T, Cooper RM, Dabrowski M, Hansen PR, Almaas VM, Seggewiss H, Horstkotte D, Adlova R, Berg JT, Bundgaard H, Veselka J. Effect of impaired cardiac conduction after alcohol septal ablation on clinical outcomes: insights from the Euro-ASA registry. Eur Heart J Qual Care Clin Outcomes. 2019 Jul 1;5(3):252-258. doi: 10.1093/ehjqcco/qcy049.
- Veselka J, Jensen MK, Liebregts M, Januska J, Krejci J, Bartel T, Dabrowski M, Hansen PR, Almaas VM, Seggewiss H, Horstkotte D, Tomasov P, Adlova R, Bundgaard H, Steggerda R, Ten Berg J, Faber L. Long-term clinical outcome after alcohol septal ablation for obstructive hypertrophic cardiomyopathy: results from the Euro-ASA registry. Eur Heart J. 2016 May 14;37(19):1517-23. doi: 10.1093/eurheartj/ehv693. Epub 2016 Jan 7.
- Veselka J, Jensen M, Liebregts M, Cooper RM, Januska J, Kashtanov M, Dabrowski M, Hansen PR, Seggewiss H, Hansvenclova E, Bundgaard H, Ten Berg J, Hilton Stables R, Faber L. Alcohol septal ablation in patients with severe septal hypertrophy. Heart. 2020 Mar;106(6):462-466. doi: 10.1136/heartjnl-2019-315422. Epub 2019 Aug 30.
- Veselka J, Faber L, Liebregts M, Cooper R, Januska J, Krejci J, Dabrowski M, Hansen PR, Seggewiss H, Horstkotte D, Hansvenclova E, Bundgaard H, Ten Berg J, Jensen MK. Long-term outcome of repeated septal reduction therapy after alcohol septal ablation for hypertrophic obstructive cardiomyopathy: insight from the Euro-ASA registry. Arch Med Sci. 2020 Aug 10;16(5):1239-1242. doi: 10.5114/aoms.2020.97969. eCollection 2020. No abstract available.
- Veselka J, Tomasov P, Zemanek D. Long-term effects of varying alcohol dosing in percutaneous septal ablation for obstructive hypertrophic cardiomyopathy: a randomized study with a follow-up up to 11 years. Can J Cardiol. 2011 Nov-Dec;27(6):763-7. doi: 10.1016/j.cjca.2011.09.001. Epub 2011 Oct 14.
- Liebregts M, Vriesendorp PA, Mahmoodi BK, Schinkel AF, Michels M, ten Berg JM. A Systematic Review and Meta-Analysis of Long-Term Outcomes After Septal Reduction Therapy in Patients With Hypertrophic Cardiomyopathy. JACC Heart Fail. 2015 Nov;3(11):896-905. doi: 10.1016/j.jchf.2015.06.011. Epub 2015 Oct 7.
- Liebregts M, Faber L, Jensen MK, Vriesendorp PA, Januska J, Krejci J, Hansen PR, Seggewiss H, Horstkotte D, Adlova R, Bundgaard H, Ten Berg JM, Veselka J. Outcomes of Alcohol Septal Ablation in Younger Patients With Obstructive Hypertrophic Cardiomyopathy. JACC Cardiovasc Interv. 2017 Jun 12;10(11):1134-1143. doi: 10.1016/j.jcin.2017.03.030.
- Liebregts M, Steggerda RC, Vriesendorp PA, van Velzen H, Schinkel AF, Willems R, van Cleemput J, van den Berg MP, Michels M, ten Berg JM. Long-Term Outcome of Alcohol Septal Ablation for Obstructive Hypertrophic Cardiomyopathy in the Young and the Elderly. JACC Cardiovasc Interv. 2016 Mar 14;9(5):463-9. doi: 10.1016/j.jcin.2015.11.036.
- Liebregts M, Vriesendorp PA, Steggerda RC, Schinkel AF, Balt JC, Ten Cate FJ, Michels M, Ten Berg JM. Effect of alcohol dosage on long-term outcomes after alcohol septal ablation in patients with hypertrophic cardiomyopathy. Catheter Cardiovasc Interv. 2016 Nov 15;88(6):945-952. doi: 10.1002/ccd.26448. Epub 2016 Mar 4.
- 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.
- Wigle ED, Sasson Z, Henderson MA, Ruddy TD, Fulop J, Rakowski H, Williams WG. Hypertrophic cardiomyopathy. The importance of the site and the extent of hypertrophy. A review. Prog Cardiovasc Dis. 1985 Jul-Aug;28(1):1-83. doi: 10.1016/0033-0620(85)90024-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2021
Primary Completion (Anticipated)
May 1, 2025
Study Completion (Anticipated)
May 1, 2026
Study Registration Dates
First Submitted
November 16, 2020
First Submitted That Met QC Criteria
December 23, 2020
First Posted (Actual)
December 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL73176.100.20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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