- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04231201
Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography (TAVI)
Aortic Stenosis: Evaluation of Severity Before and After Transcatheter Aortic Valve Implantation by Means of Ballistocardiography and Seismocardiography.
Calcific aortic stenosis (AS) (formerly "senile" or "degenerative") is a frequent disease of heart valves and is characterized by a thickness and calcification of leaflets with a significant increase of the pressure gradient, defined as an aortic jet velocity of > 2 m/s. Whenever the aortic jet velocity is > 4 m/s, in association with an aortic valve area of < 1 cm2, the disease is classified as severe and cardiac outflow obstruction develops. AS affects 1-2% of population aged of > 65 years and 12% of those aged > 75 years. Among those aged > 75 years, it is estimated that 3.5% has severe AS. With the aging of population, the prevalence of AS is expected to increase in the forthcoming years. Transcatheter Aortic Valve Implantation (TAVI) has been introduced in 2004 and consists in percutaneous replacement of the aortic valve. It is indicated in those patients with severe AS who cannot undergo surgical replacement because of high surgical risk. TAVI seems to be a good alternative to surgical intervention also for patients deemed at intermediate risk, especially if they are frail or aged. Ballistocardiography (BCG) consists of the measurement of the body's accelerations as a consequence of the recoil forces generated by the blood mass ejection at each cardiac contraction and recorded on the body's surface close to the subject's center of mass. Seismocardiography (SCG) records the heart-induced accelerations generated at each cardiac contraction and transmitted to the local chest surface. Thanks to specific algorithms applied to the SCG and BCG waves, it is possible to compute the kinetic energy (KE) and Power (P) of a single cardiac contractile cycle.
The aims of our study are to demonstrate that: LVOT Vmax and LVOT VTI changes obtained with echocardiography can be estimated reliably throught BCG and SCG signals, before and after TAVI procedure; Pmax and KE computed from the BCG and SCG signals could predict the severity of the AS before the TAVI procedure.
KE and P computed from non invasively recorded BCG and SCG waves may prove useful in the evaluation of AS severity and its evolution before and after TAVI procedure, respectively.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Bruxelles, Belgium, 1070
- Erasme hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patient population studied: patients with aortic stenosis planned to undergo TAVI procedure.
Number of patients planned: since this is a pilot study, no formal simple size calculation can be done. The Cardiology department of the Erasme hospital perform an average of 3 TAVI procedure a month. Since the enrollment will take place from January to September 2023, a total of 135 patients will be enrolled. Because of a complication rate of 10% linked to the invasive procedure, we expect 100 patients will be enrolled.
Description
Inclusion Criteria:
- Severe aortic stenosis, planned to undergo TAVI procedure
Exclusion Criteria:
- Concomitant heart valve disease other than AS
- C2 and D2 stages of AS according to the current definition (see table I for further details)
- Heart failure regardless to the etiology
- Arrhythmias
- Severe kidney disease
- Denied consent to participate
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of cardiac kinetic energy before and after aortic valve replacement by the means of modern micro-accelerometers and gyroscopes, namely ballistocardiography (BCG) and seismocardiography (SCG).
Time Frame: 3 years
|
Kinetic energy (1/2 mv^2, J) and its temporal integral are computed from the BCG and SCG signals before and after valvular replacement.
|
3 years
|
Measurement of cardiac Power before and after aortic valve replacement by the means of modern micro-accelerometers and gyroscopes, namely ballistocardiography (BCG) and seismocardiography (SCG).
Time Frame: 3 years
|
Maximal power (F*v, J/s)* produced during a contractile cycle is computed from the BCG and SCG signals before and after valvular replacement. * F= Force (mass*acceleration) (Kg*m/s^2) v= velocity (m/s) |
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of LV twist and global longitudinal strain before and after valvular replacement
Time Frame: 3 years
|
From 2 dimensional speckle tracking imaging (2D-STI) echocardiography, LV twist (°) and global longitudinal strain (°) will be measured before and after valvular replacement
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2019/596
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Stenosis
-
Hospices Civils de LyonRecruiting
-
Abbott Medical DevicesActive, not recruitingSevere Aortic Stenosis | Symptomatic Degenerative Aortic StenosisSpain, Italy, United Kingdom, Germany, Switzerland, Czechia, Australia, Belgium, Poland
-
Edwards LifesciencesActive, not recruitingAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Anteris Technologies Ltd.Active, not recruitingAortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisGeorgia
-
Anteris Technologies Ltd.Active, not recruitingAortic Stenosis | Aortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisUnited States
-
Edwards LifesciencesCompletedAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Ningbo Jenscare Biotechnology Co., Ltd.UnknownAortic Regurgitation | Severe Aortic Stenosis
-
Genesis Medtech CorporationRecruitingDiseases of Aortic Valve | Aortic Stenosis DiseaseChina
-
Saint Petersburg State University, RussiaNot yet recruitingIschemic Heart Disease | Mitral Insufficiency | Aortic Stenosis, Severe | Mitral Stenosis | Aortic Insufficiency | Ascending Aortic Aneurysm | Mitral Stenosis With Insufficiency | Tricuspid InsufficiencyRussian Federation
-
Pan XiangbinRecruiting