Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography

NCT04231201 | Suspended

• 1 other identifier: P2019/596
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Stenosis

Keywords

Ballistocariodgraphy; Seismocardiography; LV mechanics

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Measurement of LV twist and global longitudinal strain before and after valvular replacement

  3 years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Severe aortic stenosis, planned to undergo TAVI procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Sofia Morra, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 18, 2020
• Study Start: January 31, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

BE (1)