The AdaptResponse study is a prospective, randomized, controlled, interventional, single-blinded, multi-center, post-market, global Cardiac Resynchronization Therapy (CRT) in heart failure (HF) clinical study. The purpose of this clinical study is…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To test the hypothesis that AdaptivCRT® reduces the incidence of the combined
endpoint of all-cause mortality and intervention for heart failure
decompensation, compared to standard CRT therapy, in patients with a CRT
indication, LBBB and normal AV conduction. Intervention for heart failure
decompensation (HF event) is defined as an event requiring *invasive
intervention (i.e. IV diuretics, ultrafiltration, or equivalent)* or inpatient
hospitalization*.
Secondary outcome
•To test the hypothesis that aCRT ON reduces all-cause mortality compared to
aCRT OFF.
•To test the hypothesis that aCRT ON reduces the rate of intervention for heart
failure decompensation compared to aCRT OFF.
•To test the hypothesis that aCRT ON increases the proportion of patients that
improve on the Clinical Composite Score (CCS) compared to aCRT OFF, at 6 months
of follow-up.
•To test the hypothesis that aCRT ON reduces the incidence of AF compared to
aCRT OFF.
•To test the hypothesis that the change in quality of life, measured by the
KCCQ, in the aCRT ON group is better than the change in the aCRT OFF group.
•To test the hypothesis that the change in health outcome, measured by the
EQ-5D, in the aCRT ON group is better than the change in the aCRT OFF group.
•To test the hypothesis that aCRT reduces the incidence of all-cause
re-admissions after a heart failure (HF) admission within 30-days of the index
event.
•To assess cost-effectiveness of CRT devices with the aCRT algorithm relative
to traditional CRT devices.
Background summary
CRT is an established therapy for patients with HF symptoms, left ventricular
systolic dysfunction, and a wide QRS. However, the magnitude of clinical and
hemodynamic benefit of CRT varies significantly among its recipients with no
clinical improvement in approximately one third. Evidence from the Medtronic
pre-market approval aCRT study has demonstrated that aCRT-optimized CRT is at
least as effective as echo optimized BiV pacing in terms of CCS (73.6% improved
in aCRT arm vs. 72.5% in echo optimized arm, with a non-inferiority margin of
12%, p=0.0007). Additionally, a comparison with a historical echocardiographic
AV-optimized CRT cohort indicated that the aCRT algorithm increased the
proportion of patients with an improved CCS by 11.9% (95% CI: 2.7% to
19.2%).Importantly, a post-hoc sub-analysis of the Adaptive CRT Clinical Study
showed that in patients with sinus rhythm, normal AV conduction and LBBB, more
aCRT patients improved in their CCS compared with the echo arm (80.7% vs.
68.4%, p=0.04). In this subgroup the aCRT patients received LV-only pacing
64.0% ± 32.8% of the time.Additionally, in an unpublished analysis on extended
follow-up duration in patients with normal AV conduction, there was a lower
risk of death or HF hospitalization (HR=0.71, 95% CI: 0.40-1.27, p=0.25) with
aCRT. Also a greater proportion of aCRT patients improved in CCS at 6 (81%
vs.69%, p=0.041) and 12 months (77% vs. 66%, p=0.076) than
echocardiography-optimized control patients. Furthermore, over the longer term
follow-up (20.2 + 5.9 months) the aCRT algorithm has been shown to reduce the
risk of the incidence of 48 consecutive hours in AF (HR=0.54 [95% CI
0.31-0.93]; p=0.03) and aCRT patients without history of AF were less likely to
develop persistent AF (HR=0.44 [95% CI 0.19-1.03]; p=0.05).Further
investigation of clinical outcomes over longer follow-up is needed to support
the benefit of aCRT. Therefore the AdaptResponse study is designed to test the
hypothesis that the aCRT algorithm reduces the incidence of total mortality and
heart failure decompensation events, increases the proportion of patients with
an improved CCS and reduces the incidence of persistent or permanent AF in CRT
patients with normal AV conduction and LBBB.
Study objective
The AdaptResponse study is a prospective, randomized, controlled,
interventional, single-blinded, multi-center, post-market, global Cardiac
Resynchronization Therapy (CRT) in heart failure (HF) clinical study. The
purpose of this clinical study is to test the hypothesis that market released
CRT devices which contain the AdaptivCRT® (aCRT) algorithm have a superior
outcome compared to standard CRT devices in CRT indicated patients with normal
AV conduction and left bundle branch block (LBBB).
Study design
Following enrollment and baseline assessment, eligible subjects will be
implanted with a CRT system containing the aCRT algorithm and randomized in a
1:1 fashion to either treatment (aCRT ON) or control (aCRT OFF) groups. Study
subjects will be followed for a minimum of 24 months or until study closure,
whichever comes first.
Intervention
Randomization to aCRT ON versus aCRT OFF (programming of the aCRT) and the 2
questionnaires
Study burden and risks
There is no additional risk for subjects participating in the study.
Endepolsdomein 5
Maastricht 6229GW
NL
Endepolsdomein 5
Maastricht 6229GW
NL
Listed location countries
Age
Inclusion criteria
* Subject is indicated for a CRT device according to local guidelines.
* Subject has, minimally:
o Sinus Rhythm at time of enrollment.
o Left Bundle Branch Block (LBBB)
o Intrinsic, normal AV conduction
o Left ventricular ejection fraction less than or equal to 35%
o NYHA class II, III or IV
Exclusion criteria
* Subject is not expected to remain available for at least 2 years of follow-up
visits.
* Subject has permanent atrial arrhythmias for which pharmacological therapy
and/or
cardioversion have been unsuccessful or have not been attempted
* Subject is, or previously has been, receiving CRT.
Design
Recruitment
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 | NCT02205359 |
| CCMO | NL50365.041.14 |