Aortic Valve StenosisPRAM-TAVINCT03385785
Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure
An observational study of Aortic Valve Stenosis and Ventricular Dysfunction, Left, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Ventricular Dysfunction, Left
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2017to 1 Nov 2018
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Any patients hospitalized for TAVI
Who may be able to join
- Age >18 years
- elective TAVI intervention with femoral access
- consent
Who cannot join
- permanent arrhythmias
- pacemaker dependency
- moderate to severe mitral or tricuspid valve regurgitation
- intracardiac shunt
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
FRITZ
Nancy, 54000
Caroline FRITZ, MD, +33383157379, c.fritz@chru-nancy.fr
Bruno LEVY, MD,PhD, +33383154469, b.levy@chru-nancy.fr
About this study
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:
Read more
- 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
- Keywords
- Transcatheter aortic valve replacement, Pressure Recording Analytical Method, Ventriculo-arterial coupling, Monitoring, Hemodynamic
- Medical subject headings
- Aortic Valve Stenosis, Ventricular Dysfunction, Left
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcatheter aortic valve implantation (TAVI) impact on cardiac energy performance
Mesurement of the cardiac cycle efficency (CCE) by PRAM method (Pressure Recording Analytical Method)
Measured: 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
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)
Measured: Change from baseline at 24 hours after transcatheter aortic valve implantation
Myocardial ischemia risk
Buffington index (calculated as : mean arterial pressure / heart rate)
Measured: Change from baseline at 24 hours after transcatheter aortic valve implantation
Myocardial ischemia
Serum troponin level
Measured: Change from baseline at 24 hours after transcatheter aortic valve implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start14 Sep 2017
- Primary completion1 May 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline FRITZ, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385785
- Sponsor's protocol ID
- RNI2017/PRAMTAVI-FRITZ/YB
- Acronym
- PRAM-TAVI
- Status last verified
- Sep 2017
- First submitted
- 24 Oct 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventriculo-arterial Coupling Modification Evaluated by PRAM (Pressure Recording Analytical Method) in the Aortic Stenosis Treated by TAVI (Transcatheter Aortic Valve Implantation)
- ClinicalTrials.gov ID
- NCT03385785
- Acronym / sponsor ID
- PRAM-TAVI / RNI2017/PRAMTAVI-FRITZ/YB
- Keywords
- Transcatheter aortic valve replacement, Pressure Recording Analytical Method, Ventriculo-arterial coupling, Monitoring, Hemodynamic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any patients hospitalized for TAVI
Key inclusion criteria (3 listed)
- Age >18 years
- elective TAVI intervention with femoral access
- consent
Key exclusion criteria (4 listed)
- permanent arrhythmias
- pacemaker dependency
- moderate to severe mitral or tricuspid valve regurgitation
- intracardiac shunt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Echocardiographic cardiac energy performance modification after transcatheter aortic valve implantation
Time frame: Change from baseline at 24 hours after transcatheter aortic valve implantation
Myocardial ischemia risk
Time frame: Change from baseline at 24 hours after transcatheter aortic valve implantation
Myocardial ischemia
Time frame: Change from baseline at 24 hours after transcatheter aortic valve implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
Related trials for Aortic Valve Stenosis
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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Human Experimental Models of Pain (HEMP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline FRITZ, MD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Ventricular Dysfunction, Left, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline FRITZ, MD (+33383157379, c.fritz@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcatheter aortic valve implantation (TAVI) impact on cardiac energy performance (time frame: Change from baseline CCE at 30 minutes after transcatheter aortic valve implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.