Validation study of HeartOS: Recording Electrocardiogram and Systolic Time Intervals in patients undergoing surgical replacement or repair of aortic valve - HeartOs-AVD Validation

Fourth Frontier Technologies Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•o Adolescent/Adult Subjects with a known diagnosis of AS/AI as diagnosed by a physician either clinically or by means of a diagnostic device to form the study group.
•o Patients with any concomitant cardiac abnormalities (not critical) may also be included.
•o Patients with co-existing Hypertension, Diabetes Mellitus and Hypercholesterolemia can be included.
•o Age: > 12 years of age of both genders.
•o Subjects admitted to inpatient for a scheduled corrective surgical Aortic Valve replacement /reconstruction and Subjects sent for a cardiac check-up for follow up in the OPD/Clinic.
•o Informed Consent as documented by the signature (Appendix: Assent Form (FOR Adolescents <18y & Informed Consent Form).

•o Subjects < 12 years of age.
•o Subjects with a critical underlying cardiac problem, or obstructive left-sided heart lesions.
•o Subjects on a ventilator or any other kind of life support system.
•o Subjects assessed to be in a serious or life-threatening situation due to any cause e.g. significant concomitant disease states (renal failure, major neurological deficits, hepatic dysfunction, etc.).
•o Pregnancy.
•o Known or suspected non-compliance, drug or alcohol abuse.
•o Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

发起方

Fourth Frontier Technologies Pvt Ltd