Validation study of HeartOS: Recording Electrocardiogram and Systolic Time Intervals in patients with Congenital Heart Defect

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

暂无简介。

•o Subjects admitted to inpatient for a scheduled corrective surgical or percutaneous intervention or subjects sent for a cardiac check-up in the OPD/Clinic.
•o Age: > 6 months of age of both genders.
•o Pediatric/Adult Subjects with a known diagnosis of CHD (including ASD, VSD, PDA, TOF and Congenital Structural Valve Defects (including patients with Pulmonic and Aortic stenosis scheduled for Balloon Dilatation) as diagnosed by a physician either clinically or by means of a diagnostic device to form the study group.
•o Pediatric/Adult patients without any underlying cardiac disorders/ medical conditions and cleared to be healthy by qualified medical personnel to form the control group that will be matched for both age and gender with the study group.
•o Informed Consent as documented by the signature (Appendix: Assent Form (FOR CHILDREN 7 to < 18 years of age & Informed Consent Form).

•o Subjects < 6 months 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 (e.g., renal failure, major neurological deficits, hepatic dysfunction, etc.).
•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