Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT02669134 |
Other study ID # |
147-2015-PL |
Secondary ID |
|
Status |
Withdrawn |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
March 2016 |
Est. completion date |
September 2018 |
Study information
Verified date |
August 2023 |
Source |
Aston University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The main objective of the CRICKET study is demonstrate that AV and VV optimization using SonR
improves LV reverse remodeling response to CRT, compared with 'Fixed Settings' (FS) after 6
months of treatment. In this investigator-initiated, multi-centre, 2:2 factorial design,
randomized, two-arm, double-blinded, cross-over, prospective trial, CRT recipients will be
randomized to 'SonR' atrioventricular (AV) and ventricular-ventricular (VV) optimization or
'fixed settings'. The primary endpoint is an absolute reduction in left ventricular
end-systolic volume.
Description:
This is an investigator-initiated, multi-centre, 2:2 factorial design, randomized, two-arm,
double-blinded, cross-over, prospective trial
Main study objectives
The main objective of the CRICKET study is demonstrate that AV and VV optimization using SonR
improves LV reverse remodeling response to CRT, compared with 'Fixed Settings' (FS) after 6
months of treatment.
Study endpoints
Primary endpoint: The primary endpoint is a reduction (absolute difference) in LVESV with
SonR vs FS after 6 months of treatment. The difference intra-patient of absolute change of
LVESV value will be compared between two treatments: "SonR optimization" vs. "FS", defined as
a sensed AV delay of 125 ms, VV delay of 0 ms (simultaneous).
Secondary endpoints:
Change in 6 MWT distance Change in NYHA class Change in quality of life Change in patient
global assessment (EQ-5D) Change in Quality of life (MLWHF questionnaire) Change in LVEF AF
burden Adverse Events
Number of subjects
Two hundred (200) patients will be enrolled. All patients will be implanted with the SonRtip
bipolar atrial lead and a LivaNova (Sorin) CRT-D device offering both SonR optimization
algorithm and atrio-biventricular pacing. Patients will be assigned to either the treatment
or control arms, employing a 1:1 randomization with up to 100 patients in each of the 2
groups: Study Group (SonR CRT Optimization programmed "AV+VV") and Control Group ("Fixed
Settings" (FS), defined as a sensed AV delay of 125 ms, VV delay of 0 ms (simultaneous); SonR
CRT Optimization programmed "Off"). After the first 6 months, patients will be crossed-over
to the alternative arm for another 6 months. There will be no washout period.
Duration of the clinical investigation
The study inclusion phase is expected to last approximately 1.5 years.
Follow-ups
Patients will be evaluated at baseline and randomized prior to implantation to SonR
optimization or FS. A further clinical assessment, ECG and echocardiography will be
undertaken at 6 months. At this point, patients will be crossed over to the other arm for
another 6 months. The study closes following a further clinical and echocardiographic
assessment at 12 months.