Aortic Valve Stenosis Clinical Trial
Official title:
Ventriculo-arterial Coupling Modification Evaluated by PRAM (Pressure Recording Analytical Method) in the Aortic Stenosis Treated by TAVI (Transcatheter Aortic Valve Implantation)
Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America.
Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta
and leads to morphological changes in the left ventricle and hemodynamic modifications.
Intrinsic ventricular performance can be characterized using three parameters:
- Ventricular elastance (Ees for End Systolic Elastance) which represents the index of
ventricular contractility independently of the load.
- Arterial elastance (Ea for Arterial Elastance) which represents the post-load
- The ventriculo-arterial coupling index (Ees / Ea) which represents energy efficiency.
For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve
Implantation) is recommended for aortic valve replacement. Many complications may occur after
TAVI (haemorrhagic, embolic, renal, myocardial ischemia). Post-TAVI complications may also be
cardiac decompensation of the underlying cardiac disease to cardiogenic shock. However,
literature on left ventricular performance after aortic valvular replacement is poor because
of the difficulty and invasiveness of the analysis involved.
Cardiac energy analysis plays an additional role in understanding the clinical patients
conditions. On this point, cardiac energy modifications, based on ventriculo-arterial
coupling, could be indicators of cardiac function. Two methods (ultrasound and pulse contour)
are used to understand and explore the ventriculo-arterial coupling, preload, postload,
contractility and hemodynamic changes interactions.
Echocardiography allows the Ees / Ea and SW / PVA (Stoke work/ pressure-volume area) ratios
mesurements. PRAM (Pressure Recording Analytical Method) through the MostCare® monitor, gives
common hemodynamic parameters and more specific parameters such as arterial elastance (Ea)
cardiac cycle efficiency (CCE), dP / dt. Cardiac cycle efficiency (CCE) is an exclusive
variable that describes the hemodynamic performance in terms of energy expenditure in the
patient being followed.
TAVI procedure is an acute model of ventriculo-arterial coupling modification by treatment of
the ventricular ejection obstacle. The PRAM method evaluates the ventriculo-arterial
coupling. The aim of our study is to evaluate by PRAM the changes in cardiac energy variables
before and after aortic valve replacement by TAVI
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03186339 -
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
|
||
| Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
| Terminated |
NCT02854319 -
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System
|
N/A | |
| Recruiting |
NCT05601453 -
The ReTAVI Prospective Observational Registry
|
||
| Withdrawn |
NCT05481814 -
CPX in Paradoxical Low Flow Aortic Stenosis
|
||
| Completed |
NCT02241109 -
Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity
|
N/A | |
| Completed |
NCT01700439 -
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
|
N/A | |
| Recruiting |
NCT04429035 -
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
|
N/A | |
| Completed |
NCT04103931 -
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
|
N/A | |
| Completed |
NCT03950440 -
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
|
||
| Active, not recruiting |
NCT02661451 -
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
|
N/A | |
| Completed |
NCT02758964 -
Evaluation of Cerebral Thrombembolism After TAVR
|
||
| Completed |
NCT02792452 -
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
|
||
| Completed |
NCT02847546 -
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
|
N/A | |
| Not yet recruiting |
NCT02541877 -
Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve
|
Phase 3 | |
| Not yet recruiting |
NCT02536703 -
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
|
Phase 3 | |
| Completed |
NCT02249000 -
BIOVALVE - I / II Clincial Investigation
|
N/A | |
| Not yet recruiting |
NCT02221921 -
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
|
N/A | |
| Active, not recruiting |
NCT02080299 -
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
|
Phase 2 | |
| Terminated |
NCT01939678 -
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
|