Trials / Unknown
UnknownNCT04230551
Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction
Reverse Remodeling After PTSMA in Severe But ASympTomAtic LVOT Obstruction (RASTA Study)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- St. Antonius Hospital · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
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)
Conditions
- HOCM, Hypertrophic Obstructive Cardiomyopathy
- LVOTO - Left Ventricular Outflow Tract Obstruction
- Remodeling, Ventricular
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | PTSMA | Alcohol Septal Ablation |
Timeline
- Start date
- 2020-01-21
- Primary completion
- 2023-12-31
- Completion
- 2024-01-01
- First posted
- 2020-01-18
- Last updated
- 2021-09-16
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04230551. Inclusion in this directory is not an endorsement.