ext Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure Patients NOTICE-HF - NOTICE-HF

Boston Scientific0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical study;
•Patients whose age is 18 or above, or of legal age to give informed consent specific to national law
•Patients indicated for an ICD according to normal clinical practice (for those patients receiving an INCEPTA ICD).
•o As soon as 20 ICD patients are included in the study for purpose I, only NYHA Class III patients will be allowed in the study*. NYHA class should be documented in the last 3 months.
•NYHA Class III patients indicated for a CRT-D according to normal clinical practice (for those patients receiving an INCEPTA CRT-D). NYHA class should be documented in the last 3 months.

•Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician*s discretion)
•Enrolled in any other concurrent study.
•Inability or refusal to comply with the follow-up schedule
•Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
•Patients prescribed to positive airway pressure therapy
•A life expectancy of less than 1 year, per physician discretion
•Patient in NYHA Class IV during the last 4 weeks
•Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult

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