Aortic StenosisTAVINCT04231201
Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography
An observational study of Aortic Stenosis, run by Erasme University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Stenosis
- How many people
- 135 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2020to 30 Sep 2024
- 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 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Severe aortic stenosis, planned to undergo TAVI procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Aortic Stenosis
- Keywords
- Ballistocariodgraphy, Seismocardiography, LV mechanics
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 3 years
Secondary outcomes (1)
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start31 Jan 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Why it stopped: COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic 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
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Morra, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231201
- Sponsor's protocol ID
- P2019/596
- Acronym
- TAVI
- Status last verified
- Apr 2021
- First submitted
- 6 Jan 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Stenosis: Evaluation of Severity Before and After Transcatheter Aortic Valve Implantation by Means of Ballistocardiography and Seismocardiography.
- ClinicalTrials.gov ID
- NCT04231201
- Acronym / sponsor ID
- TAVI / P2019/596
- Conditions
- Aortic Stenosis
- Keywords
- Ballistocariodgraphy, Seismocardiography, LV mechanics
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID pandemic
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Jan 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Severe aortic stenosis, planned to undergo TAVI procedure
Key exclusion criteria (6 listed)
- 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
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
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.
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)
1 secondary outcome
Measurement of LV twist and global longitudinal strain before and after valvular replacement
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Sofia Morra, MD principal investigator
Erasme University Hospital
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 Stenosis, run by Erasme University Hospital at 1 site in Belgium.
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 1 inclusion and 6 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: paused, as of the sponsor's last update on 15 Apr 2021. 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. 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 15 Apr 2021.