The primary objective is to show the benefit of SmartDelay* in patients with a prolonged RV-LV interval.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
There may be no additional benefit to the subject due to the study specific
programming. However, medical science and future patients may benefit from
their participation in this clinical study. If there is a superior or inferior
arm, the subjects can be programmed at the conclusion of the study to the best
programming suitable to their needs.
Secondary outcome
Not applicable
Background summary
SMART CRT is a prospective, double-blind, multicenter, international,
randomized controlled trial. This study design helps assure that two comparable
patient populations are obtained while mitigating bias such that any observed
changes are due to the use of SmartDelay alone. The primary objective is to
show the benefit of SmartDelay in patients with a prolonged RVLV interval
defined as an increase in ejection fraction at 6 months compared to baseline.
The RV-LV interval will be measured at the Post-Implant Assessment for all
subjects enrolled and implanted with a BSC X4 CRT-D system. For those subjects
identified with an RV-LV *70ms, 1:1 randomization will occur via the electronic
data capture (EDC) system. Subjects will be randomized to have either an AV
Delay and pacing chamber determined by SmartDelay or a Fixed AV Delay of 120ms
with BiV pacing. Those subjects identified with an RV-LV < 70ms will be exited
from the study after 30 day contact to assess for any reportable safety events.
Commercially approved quadripolar Boston Scientific (BSC) Cardiac
Resynchronization Therapy Defibrillator (CRT-D) devices and future generations
of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be
included in the trial. All devices utilized in the study will include
SmartDelay* and must be capable of providing SmartDelay recommendations for
both biventricular pacing (BiV) and Left Ventricular (LV) only pacing.
Additionally, all CRT-D devices will utilize LV VectorGuide*. A commercially
approved BSC Right Atrial (RA) lead and Right Ventricular (RV) lead are
recommended to be included in this study, but any commercially available RA
lead and RV lead from any manufacturer are eligible. Boston Scientific*s
ACUITY* X4 IS4 heart failure lead family for the LV lead will be required.
The study will be conducted at up to 100 sites globally. An estimated 726
subjects will be enrolled in the study in order to achieve a target of at least
370 subjects to complete the Six Month Follow-Up.
Study objective
The primary objective is to show the benefit of SmartDelay* in patients with a
prolonged RV-LV interval.
Study design
SMART CRT is a prospective, double-blind, multicenter, international,
randomized controlled trial.
Intervention
One group that will have their CRT-D device programmed according to the
SmartDelay algorithm
One group that will have their CRT-D device programmed according to a fixed
timing interval of 120ms.
Study burden and risks
The implantable device systems and accessories used for this clinical study
will be commercially available and are considered to be standard of care for
patients indicated for such implants. The risks involved with subject
participation in this study are essentially the same as those for patients not
participating in the study.
There may be no additional benefit to the subject due to the study specific
programming. However, medical science and future patients may benefit from
their participation in this clinical study. If there is a superior or inferior
arm, the subjects can be programmed at the conclusion of the study to the best
programming suitable to their needs.
Lambroekstraat 5D
Diegem 1831
BE
Lambroekstraat 5D
Diegem 1831
BE
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03089281 |
| CCMO | NL63340.029.17 |