Health Condition 1: null- Congestive Heart Failure Subjects
Conditions
Interventions
Intervention1: Digital Ballistocardiography: Digital Ballistocardiograph Collection
Subjects will be instructed to lie down in a supine position to have their dBG? collection conducted for approximate
Sponsors
Heart Force Medical Inc
Max Neeman Medical International
Eligibility
Inclusion criteria
Inclusion criteria: General (For all subjects) ? Male and female volunteers ? 18 years of age or older ? Negative on the urine drug screen test (7 Panel) for all subjects and negative on the urine hCG test for all female subjects ? Ability to comprehend and be informed of the nature of the study, as assessed by trained and qualified clinical research staff ? Capable of giving written informed consent prior to study start ? Must be able to communicate effectively with clinic staff ? Availability of volunteer for the entire study duration and willingness to adhere to all protocol requirements Healthy Study Volunteers ? Non-smoking (for at least 6 months prior to the study start) and negative on the urine cotinine test ? Body Mass Index (BMI) that is within 18.5-29.9 kg/m², inclusive ? Healthy, according to: ? medical history ? 12-lead electrocardiogram (ECG; PQ or PR interval less than or equal to 210 msec) All subjects with ECGs outside of acceptable range of PQ or PR interval ≥210 ms, will have their ECG measurements repeated up to two times. If ECG measurements are still outside of acceptable range, the Principal Investigator/Sub-Investigator will determine appropriate course of action. ? Systolic blood pressure between 100-140 mmHg, inclusive, and diastolic blood pressure between 60-90 mmHg, inclusive, heart rate between 50-99 bpm, respiratory rate between 12-20 breaths per minute, oxygen saturation of greater than or equal to (≥) 97% and body temperature between 35.8ºC-37.5 ºC. All subjects with vital signs outside of acceptable range will have their vital signs repeated up to two times. If vitals are still outside of acceptable range, the Principal Investigator/Sub-Investigator will determine appropriate course of action. ? Physical examination ? Stable physical activity as determined by the Principal Investigator/Sub-Investigator (see Appendix C) Heart Failure Study Volunteers ? Patients with Left Ventricular Ejection Fraction (LVEF) of ≤ 35% as assessed by echocardiography ? Patient in sinus rhythm ? Patients with New York Heart Association (NYHA) functional class III or ambulatory class IV symptoms ? Patients with optimal medical therapy ? Patients with cardiac dyssynchrony, currently defined as a QRS duration of 120 msec
Exclusion criteria
Exclusion criteria: General (for all subjects) ? Presence of any illness within 30 days prior to the study, as determined by the Principal Investigator/Sub-Investigator ? Presence of any significant physical or organ abnormality including pectus excavatum, pectus carinatum and any other chest abnormalities as determined by the Principal Investigator/Sub-Investigator ? Known history or presence of: ? Alcohol abuse or dependence within one year prior to study start ? Drug abuse or dependence ? severe allergic reactions (including drugs, food, insect bites, environmental allergens) ? psychiatric or psychological disease including active suicidal ideation ? asthma (due to other than cardiac aetiology) ? lung disease ? neoplasm ? any history of surgical incision near the sternum area ? insomnia or any types of sleep disorders ? Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by Principal Investigator/Sub-Investigator ? Unable or unwilling to provide informed consent ? Women who are pregnant Healthy Study Volunteers ? Known history or presence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular (e.g. cardiovascular disease), pulmonary, endocrine, immunological, musculoskeletal, neurological, dermatological or hematological disease or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator ? Use of any prescription medication within 14 days prior to study start (except for hormonal contraceptives) ? Use of any over-the-counter medications (including herbal or dietary supplements and teas) within 7 days prior to study start (except for spermicidal/barrier contraceptive products Heart Failure Study Volunteers ? Patients with an Implantable Cardioverter Difibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or Pacemaker implant ? Patients with chest pain or who have had a heart attack within the past month before enrollment in the study unless deemed not clinically significant by the Investigator ? Patients that have had certain surgeries on their heart within the past three months unless deemed not clinically significant by the Investigator ? Patients with chronic fast heart beats in the upper chambers of the heart (atrial arrhythmias) ? Patients with any other medical condition, other than heart failure, likely to cause death within 6 months as determined by the Principal Investigator/Sub-Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The study aims to compare the timing duration of specific cardiac cycle events (measured in ms), specifically Aortic Valve Open (AVO), Aortic Valve Close (AVC), Mitral Valve Open (MVO) and Mitral Valve Close (MVC) using the Digital Ballistocardiograph and a commercially available echocardiograph in patients diagnosed with heart failure symptoms (i.e. NYHA functional class III or ambulatory class IV symptoms).Timepoint: 1.Primary outcome will be measured on the same day of procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To explore and describe the morphology and general characteristics of the ballistocardiographic waveform, annotation rules, timing events and amplitude in healthy and congestive heart failure subjects. 2.To collect echocardiographic parameters including Isovolumic Contraction Time (IVCT), Isovolumic Relaxation Time (IVRT), ejection fraction, stroke volume, estimated Max dP/dt, aortic valve area and mitral valve area for exploratory comparison with the digital ballistocardiography. Timepoint: 1.Secondary outcome will be measured on the same day of the proedure | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Outcome results
None listed