A ClinIcal EvaluatioN of ST Changes in a Group of PatIents havinG VentricularArrHyThmias - inSighT

SJM International Inc0 个研究点目标入组 470 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•The patient is implanted with an SJM ICD with ST Monitoring and ShockGuard• features (and remote care feature in case Merlin.net will be used);The patient, in the opinion of the investigator, will not require ventricular pacing for more than 20% of the time; The patient, in the opinion of the investigator, has or is at high risk of CAD; The patient is of or above 18 years of age; The patient is able to provide written Informed Consent prior to
•any investigational related procedure.

•The patient has longstanding persistent AF/AFl or permanent AF/AFl; The patient has documented complete heart block; The patient is known to have uncontrolled ventricular bigeminy or trigeminy (PVCs on regular basis); The patient has severe Left Ventricular Hypertrophy resulting in interventricular conduction defect (IVCD);The patient has intermittent bundle branch blocks (BBB); The patient is unable to comply with the follow up schedule; The patient is participating in another investigational device or drug investigation; The patient is pregnant or is planning to become pregnant during the duration of the investigation.

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