Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure

NCT03385785 | Unknown

• 1 other identifier: RNI2017/PRAMTAVI-FRITZ/YB
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Aortic Valve Stenosis; Ventricular Dysfunction, Left

Keywords

Transcatheter aortic valve replacement; Pressure Recording Analytical Method; Ventriculo-arterial coupling; Monitoring; Hemodynamic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Echocardiographic cardiac energy performance modification after transcatheter aortic valve implantation

  Change from baseline at 24 hours after transcatheter aortic valve implantation

• Myocardial ischemia risk

  Change from baseline at 24 hours after transcatheter aortic valve implantation

• Myocardial ischemia

  Change from baseline at 24 hours after transcatheter aortic valve implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patients hospitalized for TAVI

You may qualify if:

• Age \>18 years
• elective TAVI intervention with femoral access
• consent

You may not qualify if:

• permanent arrhythmias
• pacemaker dependency
• moderate to severe mitral or tricuspid valve regurgitation
• intracardiac shunt

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

FRITZ

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Ventricular Dysfunction

Study Officials

• Caroline FRITZ, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline FRITZ, MD

CONTACT

+33383157379; c.fritz@chru-nancy.fr

Bruno LEVY, MD, PhD

CONTACT

+33383154469; b.levy@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: December 29, 2017
• Study Start: September 14, 2017
• Primary Completion: May 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 29, 2017

Record last verified: 2017-09

Locations

FR (1)