Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure

Aortic Valve Stenosis Clinical Trial

— PRAM-TAVI  

Official title:

Ventriculo-arterial Coupling Modification Evaluated by PRAM (Pressure Recording Analytical Method) in the Aortic Stenosis Treated by TAVI (Transcatheter Aortic Valve Implantation)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03385785
• Other study ID #: RNI2017/PRAMTAVI-FRITZ/YB
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2017
• Last updated: December 20, 2017
• Start date: September 14, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: September 2017
• Source: Central Hospital, Nancy, France
• Contact: Caroline FRITZ, MD
• Phone: +33383157379
• Email: c.fritz[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2018
• Est. primary completion date: May 1, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• elective TAVI intervention with femoral access

• consent

Exclusion Criteria:

• permanent arrhythmias

• pacemaker dependency

• moderate to severe mitral or tricuspid valve regurgitation

• intracardiac shunt

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
France	FRITZ	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcatheter aortic valve implantation (TAVI) impact on cardiac energy performance	Mesurement of the cardiac cycle efficency (CCE) by PRAM method (Pressure Recording Analytical Method)	Change from baseline CCE at 30 minutes after transcatheter aortic valve implantation
Secondary	Echocardiographic cardiac energy performance modification after transcatheter aortic valve implantation	Echocardiography explorations (end diastolic diameter, end systolic diameter, diastolic wall thickness, systolic wall thickness, end diastolic volume, end systolic volume, percent fractional shortening, percent ejection fraction)	Change from baseline at 24 hours after transcatheter aortic valve implantation
Secondary	Myocardial ischemia risk	Buffington index (calculated as : mean arterial pressure / heart rate)	Change from baseline at 24 hours after transcatheter aortic valve implantation
Secondary	Myocardial ischemia	Serum troponin level	Change from baseline at 24 hours after transcatheter aortic valve implantation