Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT04230551
Status:
UNKNOWN
Last Update Posted:
2021-09-16
First Post:
2019-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction
Sponsor:
St. Antonius Hospital
Organization:
Study Overview
Official Title:
Reverse Remodeling After PTSMA in Severe But ASympTomAtic LVOT Obstruction (RASTA Study)
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RASTA
Brief Summary:
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 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.
Detailed Description:
The trial consists of three cohorts
1. Symptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (reference group)
2. Asymptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (study group)
3. Asymptomatic HOCM patients with severe LVOT obstruction with no intervention (observation group)
1. Symptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (reference group)
2. Asymptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (study group)
3. Asymptomatic HOCM patients with severe LVOT obstruction with no intervention (observation group)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: