Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography

Aortic Stenosis Clinical Trial

— TAVI  

Official title:

Aortic Stenosis: Evaluation of Severity Before and After Transcatheter Aortic Valve Implantation by Means of Ballistocardiography and Seismocardiography.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04231201
• Other study ID #: P2019/596
• Status: Suspended
• Start date: January 31, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2021
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 135
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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
Primary	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).	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	Measurement of LV twist and global longitudinal strain before and after valvular replacement	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