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Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure (PRAM-TAVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03385785
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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

Condition or disease
Aortic Valve Stenosis Ventricular Dysfunction, Left

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Ventriculo-arterial Coupling Modification Evaluated by PRAM (Pressure Recording Analytical Method) in the Aortic Stenosis Treated by TAVI (Transcatheter Aortic Valve Implantation)
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Transcatheter aortic valve implantation (TAVI) impact on cardiac energy performance [ Time Frame: Change from baseline CCE at 30 minutes after transcatheter aortic valve implantation ]
    Mesurement of the cardiac cycle efficency (CCE) by PRAM method (Pressure Recording Analytical Method)

Secondary Outcome Measures :
  1. Echocardiographic cardiac energy performance modification after transcatheter aortic valve implantation [ Time Frame: Change from baseline at 24 hours 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)

  2. Myocardial ischemia risk [ Time Frame: Change from baseline at 24 hours after transcatheter aortic valve implantation ]
    Buffington index (calculated as : mean arterial pressure / heart rate)

  3. Myocardial ischemia [ Time Frame: Change from baseline at 24 hours after transcatheter aortic valve implantation ]
    Serum troponin level

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Any patients hospitalized for TAVI

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03385785

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Contact: Caroline FRITZ, MD +33383157379
Contact: Bruno LEVY, MD, PhD +33383154469

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FRITZ Recruiting
Nancy, France, 54000
Contact: Caroline FRITZ, MD    +33383157379   
Contact: Bruno LEVY, MD,PhD    +33383154469   
Sponsors and Collaborators
Central Hospital, Nancy, France
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Principal Investigator: Caroline FRITZ, MD Central Hospital, Nancy, France

Additional Information:

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Responsible Party: Central Hospital, Nancy, France Identifier: NCT03385785     History of Changes
Other Study ID Numbers: RNI2017/PRAMTAVI-FRITZ/YB
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
Transcatheter aortic valve replacement
Pressure Recording Analytical Method
Ventriculo-arterial coupling

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Ventricular Dysfunction
Ventricular Dysfunction, Left
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction