The purpose of this study is to demonstrate that frequent AV/PV and VV delay optimization using QuickOpt* in patients with CRT-D device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this clinical investigation is to demonstrate that the
proportion of improved patients in the treatment group is superior to the
proportion in the control group, 12 months post-implantation.
The Heart Failure Clinical Composite Response22 will be used to evaluate the
status of the patient.
Secondary outcome
The secondary objectives of the study are:
* All-cause, cardiovascular and heart failure mortality;
* All-cause, cardiovascular and heart failure hospitalizations.
Background summary
Cardiac resynchronization therapy (CRT) through simultaneous biventricular
(BiV) pacing has emerged as an effective treatment in patients with heart
failure (HF). Various studies have demonstrated the clinical benefit of CRT
from improvements in quality-of-life, heart failure symptoms, exercise
capacity, mortality, and hospitalization rates1-5. These studies support the
therapeutic value of ventricular resynchronization in patients with severe HF
(NYHA class III-IV) who do not have a standard indication for the implantation
of a pacemaker.
It has been well known that atrio-ventricular (AV/PV) delay in CRT is a
critical parameter for hemodynamic performance. While the first generation CRT
devices simultaneously stimulated both the right ventricle (RV) and left
ventricle (LV), newer devices provide the capability of adjusting the
inter-ventricular (VV) pacing delay as well as the sequence of RV versus LV
stimulation. Recent clinical studies have also shown that optimization of the
VV delay during BiV pacing can incrementally improve cardiac function over
simultaneous BiV pacing6-15. However, the optimization of AV/PV and VV delays
currently relies on echocardiography and/or Tissue Doppler Imaging (TDI)
techniques, which are expensive and time consuming procedures and require
extended office visits.
St. Jude Medical has developed a novel intracardiac electrogram (IEGM) method
to estimate both the optimal AV/PV and VV delays. The IEGM based VV delay
optimization method aims to synchronize electrical activation of the conducted
intrinsic and paced wavefronts between the pacing electrodes. The IEGM based
AV/PV optimization method characterizes the inter-atrial conduction patterns in
order to maximize preload and to allow for proper timing of mitral valve
closure. Based on the positive results from preliminary studies16,17, this IEGM
based optimization method was incorporated as an automatic, programmer-based
algorithm (referred as QuickOptTM) for measuring IEGMs and recommending patient
specific optimal AV/PV and VV delays. Recently, an Investigational Device
Exemption (IDE) trial was conducted with 115 patients to determine if the
QuickOptTM optimization method showed correlation with echo optimization of
AV/PV and VV delays18. The results of this prospective, nonrandomized,
multicenter trial demonstrated a strong concordance correlation of over 96% for
the maximum aortic velocity time integral (AVTI) measured at optimal AV/PV and
VV delays between the QuickOptTM method and the AVTI echocardiography
optimization technique.
Recent studies have shown that AV/PV and VV delays change overtime and
re-optimization of these delays might be beneficial for maintaining significant
improvement of cardiac function19-21. However, the benefits of re-optimization
in terms of improvements in symptomatic status, fewer hospital admissions and
reduced mortality still need to be evaluated.
Study objective
The purpose of this study is to demonstrate that frequent AV/PV and VV delay
optimization using QuickOpt* in patients with CRT-D device results in improved
clinical response over standard of care (i.e. empiric programming or one-time
optimization using any non-IEGM optimization methods).
Study design
This clinical trial is an international, multicenter, prospective, randomized,
parallel, double-blind study designed to compare frequent AV/PV and VV delay
optimization using the QuickOpt method to standard of care (i.e. empiric
programming or one-time optimization using any non-IEGM optimization methods).
All patients taking part in this study be enrolled within 2 weeks of
implantation. At that time, the patients will berandomized in a 1:1 fashion to
one of the two groups (See figure 1):
* Control group: standard of care (i.e. empiric programming or one-time
optimization using any non-IEGM optimization methods);
* QuickOpt* group: Frequent AV/PV and VV delay optimization using QuickOpt*.
Patients are followed for 12 months, with protocol scheduled visits at 3, 6, 9
and 12 months post-implantation ( ± 2 weeks).
Study burden and risks
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Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- patient meets current CRT-D indications and be impanted with an SJM CRT-D device with V-V timing and a compatible lead system
- patient had the ability to complete a 6-minute hall walk with the only limiting factor to be fatique of shortness of breath.
- patient older than 18 year.
Exclusion criteria
- patient is less than 18 years old.
- patient has persistent of permanent AF.
- patient has the ability to walk > 450 meters in 6 minutes.
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 |
|---|---|
| CCMO | NL17480.041.07 |