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Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure

NCT ID: NCT03385785

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-14

Study Completion Date

2018-11-01

Brief Summary

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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

Detailed Description

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Conditions

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Aortic Valve Stenosis Ventricular Dysfunction, Left

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline FRITZ, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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FRITZ

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Caroline FRITZ, MD

Role: CONTACT

Phone: +33383157379

Email: [email protected]

Bruno LEVY, MD, PhD

Role: CONTACT

Phone: +33383154469

Email: [email protected]

Facility Contacts

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Caroline FRITZ, MD

Role: primary

Bruno LEVY, MD,PhD

Role: backup

Other Identifiers

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RNI2017/PRAMTAVI-FRITZ/YB

Identifier Type: -

Identifier Source: org_study_id