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Patients with HOCM and severe LVOT obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders. Hence, preventing adverse remodeling through LVOT desobstruction may have significant impact on cardiac function and geometry in this particular population, as it is in symptomatic patients.
The investigators will assess functional and structural characteristics of the myocardium in asymptomatic vs. symptomatic patients with severe LVOT obstruction before and after PTSMA, using advanced imaging studies with LGE-CMR and echocardiography.
The trial consists of three cohorts
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Group | Active Comparator | Five symptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA |
|
| Study Group | Experimental | Five asymptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA |
|
| Observation Group | No Intervention | Five asymptomatic HOCM patients with severe LVOT obstruction will not undergo PTSMA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTSMA | Procedure | Alcohol Septal Ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibrosis | Extracellular Volume Fraction | 2 years |
| Global longitudinal strain (TTE) | Diastolic Function | 2 years |
| Deformation (CMR) | Shortening Index | 2 years |
| Haemodynamics | Left and Right-Sided Pressure Gradients (TTE) | 2 years |
| 4D velocity mapping | Blood Flow | 2 years |
| LV Geometry | Volume | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Association (NYHA) classification | Exercise tolerance | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jurrien M ten Berg, MD PhD | Contact | +31 88 320 1121 | j.ten.berg@antoniusziekenhuis.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jurrien M ten Berg, MD PhD | St. Antonius Hospital | Principal Investigator |
| Fatih Arslan, MD PhD | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Hospital | Not yet recruiting | Nieuwegein | 3435CM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32808736 | Derived | 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. |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| D000092242 | Ventricular Outflow Obstruction, Left |
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Technicians and/or imaging cardiologists involved in image analysis will not be informed about the procedure in order to have an unbiased analysis at baseline. At follow-up, treated patients will have akinetic/infarcted proximal septum that will be noticed during image acquisition. However, the pre-PTSMA status (symptomatic vs. asymptomatic) will be blinded for the analysis.
| St. Antonius Hospital | Recruiting | Nieuwegein | Netherlands |
|
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |