Hypertrophic CardiomyopathyAMARONENCT04684290
Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
A study testing Alcohol Septal Ablation and Surgical Septal Myectomy in people with Hypertrophic Cardiomyopathy, run by St. Antonius Hospital at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Alcohol Septal Ablation and Surgical Septal Myectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Jun 2021to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3435cm
Jurrien ten Berg, 088 320 3000, j.ten.berg@antoniusziekenhuis.nl
About this study
Official title: 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).
Read the 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.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Alcohol Septal Ablation, Surgical Septal Myectomy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Septal AblationProcedure or surgery
Participants will be treated with alcohol septal ablation.
Surgical Septal MyectomyProcedure or surgery
Participants will be treated with surgical septal myectomy.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Septal Ablation | Active comparator | Not described Receives: Procedure: Alcohol Septal Ablation |
| Surgical Septal Myectomy | Active comparator | Not described Receives: Procedure: Surgical Septal Myectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after the invasive treatment
Secondary outcomes (22)
Number of participants with all-cause mortality
Measured: Follow up will be 1,3 and 5 years
Number of participants with cardiovascular mortality
Measured: Follow up will be 1,3 and 5 years
Number of participants with transient Ischemic Attack
Measured: Follow up will be 1,3 and 5 years
Number of participants with hospital Readmittance
Measured: Follow up will be 1,3 and 5 years
Number of participants with with occurrence of atrial fibrillation
Measured: Follow up will be 1,3 and 5 years
Number of participants with ventricular arrhythmias
Measured: Follow up will be 1,3 and 5 years
Number of participants with with complete heart block requiring permanent pacemaker implantation
Measured: 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.
Measured: First 30 days
Number of participants with re-intervention
One more time need for Alcohol septal ablation or surgical septal myectomy
Measured: Follow up will be 1,3 and 5 years
Blood sample results
Troponin T (in ug/l)
Measured: 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)
Measured: Follow up will be 1,3 and 5 years
Blood sample results
Creatine-kinase (CK in U/l)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Left ventricle ejection fraction (%)
Measured: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Left ventricle outflow tract gradient (mmHg)
Measured: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Left ventricular internal systolic and diastolic dimension (cm)
Measured: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Atrial diameter (ml/m2)
Measured: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Valvular function
Measured: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Right ventricular systolic pressure (mmHg)
Measured: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Interventricular septal thickness (mm)
Measured: Follow up will be 1,3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start30 Jun 2021
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, J.M. ten Berg, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684290
- Sponsor's protocol ID
- NL73176.100.20
- Acronym
- AMARONE
- Status last verified
- Sep 2021
- First submitted
- 16 Nov 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11711479Sherrid 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.
PubMed 19589433Authors/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.
PubMed 25173338Gersh 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.
PubMed 22068434Veselka 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.
PubMed 28512112Jensen 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.
PubMed 30304395Veselka 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.
PubMed 26746632Veselka 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.
PubMed 31471463Veselka 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.
PubMed 32864015Veselka 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.
PubMed 22000583Liebregts 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.
PubMed 26454847Liebregts 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.
PubMed 28595881Liebregts 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.
PubMed 26965935Liebregts 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.
PubMed 26946355Arslan 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.
PubMed 32808736
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04684290
- Acronym / sponsor ID
- AMARONE / NL73176.100.20
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Septal Ablation | Active comparator | Procedure: Alcohol Septal Ablation |
| Surgical Septal Myectomy | Active comparator | Procedure: Surgical Septal Myectomy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol Septal AblationParticipants will be treated with alcohol septal ablation. | Procedure or surgery | Alcohol Septal Ablation |
| Surgical Septal MyectomyParticipants will be treated with surgical septal myectomy. | Procedure or surgery | Surgical Septal Myectomy |
Primary outcome
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.
22 secondary outcomes
Number of participants with all-cause mortality
Time frame: 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
Number of participants with transient Ischemic Attack
Time frame: 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
Number of participants with with occurrence of atrial fibrillation
Time frame: 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
Number of participants with with complete heart block requiring permanent pacemaker implantation
Time frame: Follow up will be 1,3 and 5 years
Number of participants with major bleeding
Time frame: First 30 days
Number of participants with re-intervention
Time frame: Follow up will be 1,3 and 5 years
Blood sample results
Time frame: Follow up will be 1,3 and 5 years
Blood sample results
Time frame: Follow up will be 1,3 and 5 years
Blood sample results
Time frame: 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
Cardiac Magnetic Resonance Imaging (CMR) parameters
Time frame: 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
Transthoracic echocardiogram
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Time frame: Follow up will be 1,3 and 5 years
Transthoracic echocardiogram
Time frame: Follow up will be 1,3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 11711479Wigle ED. Cardiomyopathy: The diagnosis of hypertrophic cardiomyopathy. Heart. 2001 Dec;86(6):709-14. doi: 10.1136/heart.86.6.709. No abstract available.
- Background: PubMed 19589433Sherrid 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.
- Background: PubMed 25173338Authors/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.
- Background: PubMed 22068434Gersh 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.
- Background: PubMed 28512112Veselka 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.
- Background: PubMed 30304395Jensen 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.
- Background: PubMed 26746632Veselka 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.
- Background: PubMed 31471463Veselka 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.
- Background: PubMed 32864015Veselka 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.
- Background: PubMed 22000583Veselka 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.
- Background: PubMed 26454847Liebregts 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.
- Background: PubMed 28595881Liebregts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Septal Ablation and Surgical Septal Myectomy in people with Hypertrophic Cardiomyopathy, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test (time frame: 1 year after the invasive treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04684290, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.