Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>There may be no additional benefit to the subject due to the study specific<br /><br>programming. However, medical science and future patients may benefit from<br /><br>their participation in this clinical study. If there is a superior or inferior<br /><br>arm, the subjects can be programmed at the conclusion of the study to the best<br /><br>programming suitable to their needs. </p><br>

Secondary Outcome Measures