Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03667365
Status:
TERMINATED
Last Update Posted:
2023-03-01
First Post:
2018-09-10
Brief Title:
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
new US guidelines
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROTAS
Brief Summary:
According to current European Recommendations on valvular heart disease VHD classical severe aortic stenosis AS is defined by an aortic valve area AVA 1 cm2 and indexed AVA 06 cm2m2 a mean aortic pressure gradient MAG 40 mmHg and a maximal aortic velocity 4 msec
Aortic valve replacement AVR is recommended class I indication in patients with classical severe AS who have any symptoms related to aortic valve disease
In 2007 Hachicha et al described a particular pattern of severe AS characterized by an AVA 06 cm2m2 low mean pressure aortic gradient MAG 40 mmHg despite the presence of a preserved left ventricular ejection fraction LVEF 50 This pattern of AS is encountered in nearly 15-25 of patients who have severe AS Typically these patients are elderly subjects with several comorbidities a small left ventricular LV cavity with pronounced LV concentric remodeling and a restrictive physiology leading to a decrease in LV stroke volume despite a preserved LVEF The diagnosis and management of patients with low gradient severe AS and preserved LVEF are often challenging because
1 the presence of a true severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach
2 the best therapeutic management AVR versus conservative strategy of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established
In very recently updated European guidelines on the management of VHD symptomatic patients with low gradient and low flow severe AS and preserved LVEF have only a class IIa-level C indication for AVR No specific indications are given for the management of symptomatic patients with low gradient and normal flow severe AS This lack of indications is clearly attributed to a gap in knowledge which requires further investigations to be filled up
Aortic valve replacement AVR is recommended class I indication in patients with classical severe AS who have any symptoms related to aortic valve disease
In 2007 Hachicha et al described a particular pattern of severe AS characterized by an AVA 06 cm2m2 low mean pressure aortic gradient MAG 40 mmHg despite the presence of a preserved left ventricular ejection fraction LVEF 50 This pattern of AS is encountered in nearly 15-25 of patients who have severe AS Typically these patients are elderly subjects with several comorbidities a small left ventricular LV cavity with pronounced LV concentric remodeling and a restrictive physiology leading to a decrease in LV stroke volume despite a preserved LVEF The diagnosis and management of patients with low gradient severe AS and preserved LVEF are often challenging because
1 the presence of a true severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach
2 the best therapeutic management AVR versus conservative strategy of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established
In very recently updated European guidelines on the management of VHD symptomatic patients with low gradient and low flow severe AS and preserved LVEF have only a class IIa-level C indication for AVR No specific indications are given for the management of symptomatic patients with low gradient and normal flow severe AS This lack of indications is clearly attributed to a gap in knowledge which requires further investigations to be filled up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-A02100-55 | OTHER | NID-RCB | None |