The aim of this registry is to compare functional status among patients with highly symptomatic obstructive HCM despite optimal medical treatment who undergo Alcohol Septal Ablation to Surgical Septal Myectomy. This study will therefore, compare the…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study question is whether ASA is non-inferior to SSM in the
improvement of exercise capacity.
The primary endpoint is 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.
Secondary outcome
Secondary endpoints are all-cause mortality, cardiovascular mortality (defined
as death resulting from acute myocardial infarctions, sudden cardiac death,
death due to heart failure, death due to stroke, death due to cardiovascular
procedures, death due to cardiovascular hemorrhage and death due to other
cardiovascular causes) and Transient Ischemic Attack. Also readmittance,
occurrence of atrial fibrillation, ventricular arrhythmias (aborted ventricular
fibrillation, ventricular tachycardia), complete heart block requiring
permanent pacemaker implantation, and major bleeding, re-intervention, blood
sample analysis (ex. NT-pro-BNP, Troponine and creatine-kinase (CK)), symptoms
and quality of life evaluation using SF-36 questionnaire will be captured.
Follow-up will be on 1, 3 and 5 years.
Background summary
Hypertrophic cardiomyopathy (HCM) is the most common inheritable cardiac
disease. Obstruction of the left ventricular outflow tract (LVOT) at rest or
during exercise is present in the majority of patients and is referred to as
hypertrophic obstructive cardiomyopathy (HOCM). LVOT obstruction is associated
with heart failure symptoms, exertional syncope, and sudden cardiac death.
Conventional pharmacologic treatment might improve functional limitation but
has no effect on mortality. Two-dimensional (2D) echocardiography is regarded
as the initial step in evaluation of hypertrophy. However cardiac magnetic
resonance imaging (MRI) enables more precisely localization and degree of left
ventricular hypertrophy and in addition is able to quantify the extent and
distribution of myocardial fibrosis, which appears to have an impact on
outcomes. MRI is thus superior to 2D echocardiography and is therefore
recommended in the European and American guidelines. For more than 50 years
surgical septal myectomy (SSM) has been an excellent treatment to relieve LVOT
obstruction in patients with HOCM, however, for more than 2 decades already,
alcohol septal ablation (ASA) is a good alternative. Therefore, both the
European and American Guidelines recommend to consider both treatment options
in patients with severe limiting symptoms refractory to maximum medical
management and marked outflow obstruction (peak instantaneous gradient >= 50mmHg
at rest or with physiologic provocation). Observational studies suggest that
both mortality and sudden cardiac death (SCD) risk are similarly lowered in
patients after ASA and SSM. Permanent pacemaker dependency and need for
additional septal reduction therapy is higher in patients who undergo ASA
compared to SSM. In contrast, SSM compared to ASA has a much longer recovery
time as well as more thoracotomy related complications.
Study objective
The aim of this registry is to compare functional status among patients with
highly symptomatic obstructive HCM despite optimal medical treatment who
undergo Alcohol Septal Ablation to Surgical Septal Myectomy. This study will
therefore, compare the outcomes of functional status of both treatments for
symptomatic patients with HOCM.
Study design
A prospective, multicenter, registry study which two study arms, alcohol septal
ablation and surgical septal myectomy.
Intervention
Patients will be treated with transcatheter ASA or SSM according to hospitals`
local standards.
Study burden and risks
ASA, SSM and related products during the intervention, bicycle ergometry
exercise test, blood sampling, echocardiography and CMR are part of daily
clinical practice and there are no additional burden or risks.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
1. Age between 30-80 years
2. HOCM eligible for either SSM or ASA by a heart team (multi-disciplinary
team)
3. LVOT obstruction >=50 mmHg at rest or during physiological provocation by TTE
4. Symptomatic (NYHA class >=2 ) 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 intrinsic valvular disease requiring surgery in accordance with
current guidelines
4. Concomitant coronary artery disease not amendable to PCI and thus requiring
coronary artery bypass surgery
5. Not able to perform bicycle ergometry exercise test
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73176.100.20 |