DEVICE
Seismocardiography
Seismocardiography recording
Identification of Heart Failure Patients by Seismocardiography
Status
Completed
Phase
Not applicable
Enrollment
219
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The aim of the current study is to develop and validate an algorithm based on seismocardiography recordings to detect heart failure. Echocardiography will be used as the golden standard for defining patients with heart failure.
Full detailed description
Seismocardiography is inspired from methods for the analysis of seismic activity and can be used to describe the heart's movements using a specially developed sensor placed on the patient's chest. The project aims to describe the motion of the heart using automated computer analysis of the seismocardiography signal for development of a simple method for the analysis of myocardial performance.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 4, 2018
Study start
Jun 29, 2018
Primary completion
Jul 27, 2022
Study completion
Jul 27, 2022
Results posted
Not reported
Registry updated
Feb 28, 2023
Outcomes
What the study measures.
Primary outcomes
Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure.
Time frame · 1 day
Heart failure defined as heart failure with reduced ejection fraction, heart failure with mid-range ejection fraction and heart failure with preserved ejection fraction combined.
Secondary outcomes
Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography and NT-proBNP, respectively, in detection of heart failure with reduced ejection fraction
Time frame · 1 day
Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure with mid-range ejection fraction.
Time frame · 1 day
Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure with preserved ejection fraction.
Time frame · 1 day
Adverse events related to the CADScor seismo device.
Time frame · 1 day
Count of adverse events
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Male or female, aged 18 years or older * Clinically suspected heart failure, and referred to an outpatient clinic * Be able and willing to comply with the clinical investigational plan * Have signed the informed consent form Exclusion Criteria: * Known HF * Known atrial fibrillation * Acute coronary syndrome * Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD) * Implanted electronic equipment in the area above and around the heart * Significant operation scars, abnormal body shape, fragile or compromised skin in the seismocardiographic recording area (fourth left Inter Costal space and xiphoid process) * Pregnancy Extension study: Inclusion criteria 1. Male or female, aged 18 years or older 2. Newly diagnosed HFREF 3. Be able and willing to comply with the clinical investigational plan 4. Have signed the informed consent form Exclusion criteria 1. Known atrial fibrillation 2. Acute coronary syndrome 3. Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD) 4. Implanted electronic equipment in the area above and around the heart 5. Significant operation scars, abnormal body shape, fragile or compromised skin in the seismocardiographic recording area (fourth left Inter Costal space and xiphoid process) 6. Pregnancy
Study locations
2 registered sites.
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Aalborg University Hospital
Aalborg, Denmark
Odense University Hospital
Odense, Denmark
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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