Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy - SMART CRT (0393/0028)

Boston Scientific0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•* Subject must be indicated to receive a de novo quadripolar Boston Scientific
•Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an
•ACUITY X4 LV lead. This includes subjects who are indicated to receive an
•upgrade to a BSC X4 CRT-D from a previously implanted device.
•* In order to achieve a homogenous population for the study, qualifying
•subjects are those with heart failure who meet BSC US indications for use
•defined as those subjects who receive stable optimal pharmacologic therapy
•(OPT) for heart failure and who meet any one of the following classifications:
•o Moderate to severe heart failure (NYHA Class III-IV) with EF * 35% and QRS
•duration * 120 ms
•o Left bundle branch block (LBBB) with QRS duration * 130 ms, EF * 30%, and
•mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic
•(NYHA Class I) ischemic heart failure
•* Subject is age 18 or above, or of legal age to give informed consent specific
•to each country and national laws
•* Subject is willing and capable of providing informed consent
•* Subject is willing and capable of complying with visits and procedures as
•defined by this protocol

•* Subjects with documented permanent complete AV block
•* Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the
•time of enrollment
•* Subjects who have previously received cardiac resynchronization therapy with
•pacing in the left ventricle
•* Subjects on the active heart transplant list or who has or is to receive
•ventricular assist device (VAD)
•* Life expectancy shorter than 12 months due to any medical condition (e.g.,
•cancer, uremia, liver failure, etc*)
•* Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
•* Subject is enrolled in any other concurrent clinical study, with the
•exception of local mandatory governmental registries and observational
•studies/registries, without the written approval from Boston Scientific
•* Women of childbearing potential who are or plan to become pregnant during the
•course of the trial
•* Subjects currently requiring dialysis

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