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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02100-55 | Other Identifier | N°ID-RCB |
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new US guidelines
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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 ≤0.6 cm2/m2, a mean aortic pressure gradient (MAG) >40 mmHg, and a maximal aortic velocity >4 m/sec.
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 ≤0.6 cm2/m2, 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aortic valve replacement | Experimental |
| |
| strict clinical surveillance | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aortic valve replacement | Procedure | aortic valve replacement surgical or transcatheter aortic valve replacement (will be decided by the heart team before randomization) |
|
| Measure | Description | Time Frame |
|---|---|---|
| time from randomization to first occurrence of any of the components of the composite outcome (adjudicated): all-cause mortality or cardiovascular related hospitalization | during 2 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| rate of all-cause mortality | 2 years | |
| rate of cardiovascular mortality | 2 years | |
| rate of cardiovascular related hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena EG Galli, MD | Rennes University Hospital | Principal Investigator |
| Erwan ED Donal, PhD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Liège | Liège | Belgium | ||||
| CHU Amiens - Picardie |
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| strict clinical surveillance | Other | strict clinical surveillance strategy |
|
| 2 years |
| rate of cerebrovascular events | 2 years |
| walking distance | 6-minute walking test | 6, 12, 18 and 24 months |
| NT-proBNP plasma levels | 6, 12, 18 and 24 months |
| quality of life score | test EQ-5D | 6, 12, 18 and 24 months |
| Amiens |
| France |
| CHU Angers | Angers | France |
| CHU Brest - Hôpital La Cavale Blanche | Brest | France |
| APHP - CHU Henri Mondor | Créteil | France |
| CHU Dijon - Hôpital François Mitterrand | Dijon | France |
| CHU Lille | Lille | France |
| CH Bretagne Sud | Lorient | France |
| APHM - Hôpital La Timone | Marseille | France |
| Clinique du Millénaire | Montpellier | France |
| CHU Nantes | Nantes | France |
| CHU Rennes | Rennes | 35000 | France |
| CH Saint-Brieuc | Saint-Brieuc | France |
| Centre Cardiologique du Nord | Saint-Denis | France |
| CHU Toulouse - Hôpital Rangueil | Toulouse | France |
| CHU Tours - Hôpital Trousseau | Tours | France |
| CHU Nancy | Vandœuvre-lès-Nancy | France |
| CH Bretagne Atlantique - Site de Vannes | Vannes | France |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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