The purpose of this clinical investigation is to assess the impact of the MultiPoint Pacing (MPP)feature at 12 months in the treatment of patients that are not responding to standard CardiacResynchronization Therapy (CRT)
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of non-responder patients converted to responders after 6 months
of MPP feature turned ON compared to baseline, as measured by Left
Ventricular End Systolic Volume (LVESV) reduction of at least 15%
Secondary outcome
Reduction of LVESV between baseline and 6 month visit
• Packer*s Clinical Composite Score evaluation between the baseline and
the 12 month visit; and between the 6 month and the 12 month visit
• Reverse LV remodelling, measured as changes in LVESV, LVEDD and
LVEF
• NYHA Class changes
• 6 minutes walking test changes
• Quality of Life (MLWHF and EQ-5D) changes
Background summary
Cardiac resynchronization therapy (CRT) using biventricular (BiV) pacing has
been developed to
restore synchrony in HF patients with delayed ventricular activation,
predominantly of the left
ventricle (LV).
Nevertheless a majority of treated patients show a benefit, up to 40% derive no
improvement
from CRT.The cause for failed response to CRT is not completely understood;
there is a general
consensus, supported by growing evidence, that suboptimal LV lead placement
accounts for a
large percentage of patients who do not respond to CRT.
MultiPoint* pacing (MPP) is a new pacing feature in the Quadripolar CRT-D
system that allows
sequential pacing of the LV with two pacing vectors compared to one vector in a
traditional CRTD
system. A combination of any two of the 10 available vectors with
inter-stimulus delays can be
used. MPP via one LV lead may have the potential to act as an alternative to
non-invasively
optimize LV lead placement, and it may improve hemodynamics and the response to
CRT.
Since MPP delivers two pulses at programmable delays (LV1 and LV2) to two LV
sites, the initial
volume of excited cardiac tissue is increased. By capturing more mass at the
site of initial
depolarization there is a greater likelihood of pacing the site of latest
systolic delay. This method has been shown to improve LV function and it is
believed that this additional improvement in LV function may benefit those
patients who are otherwise identified as nonresponders
to conventional BiV pacing.
Study objective
The purpose of this clinical investigation is to assess the impact of the
MultiPoint Pacing (MPP)
feature at 12 months in the treatment of patients that are not responding to
standard Cardiac
Resynchronization Therapy (CRT)
Study design
This study is designed as a Prospective, Randomized, Multi-center Trial.
Intervention
All patients will get an CRT-D device implanted, after 6 months only the
non-responders are randomized in Multipoint Pacing (MPP) or no MPP.
Study burden and risks
The burden and risks associated with the study are limited. All patients will
get optimal CRT treatment, only patients not responding to the treatment are
randomized so that half of these patients get MPP which increases the chance on
a positive effect of the treatment.
The burden mainly consists of an additional cardiac ultrasound evaluation, 2
Quality of Life questionnaires, an EKG and the 6 minute hall walk test at 3
visits.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
• Meets the current ESC or ACCF/AHA/HRS Class I or Class IIa
indications for CRT implant (including upgrades from single or dual
chamber ICDs)
• Must be willing and able to comply with study requirements
• Must indicate their understanding of the study and willingness to
participate by signing an appropriate informed consent form
Exclusion criteria
• Already had a CRT device implanted
• Myocardial Infarction, unstable angina within 40 days prior the
enrollment
• Recent cardiac revascularization (PTCA, Stent or CABG) in the 4
weeks prior to enrollment or planned for the 3 months following
• Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in
the 3 months prior the enrollment
• Primary valvular disease requiring surgical correction
• Atrial Fibrillation:
- Persistent AF at the time of enrollment
- Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
- History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
• Unable to comply with the follow up schedule
• Less than 18 years of age
• Pregnant or are planning to become pregnant during the duration of the
investigation
• Classification of Status 1 for cardiac transplantation or consideration for
transplantation over the next 12 months
• Undergone a cardiac transplantation
• Life expectancy < 12 months
• Currently participating in any other clinical investigation
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 | NL46164.018.13 |
| Other | NTC02006069 |