N/A
N=440
Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03089281 ↗Enrolled (actual)
440
Serious AEs
21.6%
Results posted
Apr 2022
Primary outcome: Primary: CRT Response — 116; 105 Participants — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CRT-D (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CRT Response |
116; 105 | 0.17 |
| SECONDARY Change in Left Ventricular End Systolic Volume (Absolute Change) |
-51.5; -37.8 | 0.011 sig |
| SECONDARY Change in Left Ventricular End Systolic Volume (Relative Change) |
-33.2; -26.7 | 0.029 sig |
| SECONDARY Change in Left Ventricular Ejection Fraction (Absolute Change) |
12.6; 10.2 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction (Relative Change) |
57.5; 44.8 | 0.050 |
| SECONDARY Clinical Composite Score (CCS) |
153; 154; 31; 25; 23; 20 | 0.49 |
| SECONDARY Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score |
18.3; 20.2 | 0.36 |
Summary
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
Eligibility Criteria
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:
- Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
- 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
Data sourced from ClinicalTrials.gov (NCT03089281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.