An interventional study of SonR CRT Optimization 'On' and SonR CRT Optimization 'Off' in Heart Failure, sponsored by MicroPort CRM. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-22.
Sponsored by MicroPort CRM · Not applicable, Interventional, and Other
The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT parameters by SonR technology is able to increase the rate of CRT-D responders, based on significant LV reverse remodeling, as compared to Standard of Care settings.
This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard of care (SoC) programming methods in providing appropriate LV filling, as expected from the Ritter method.
This study will evaluate the effectiveness of CRT-D SonR system as compared to SoC programming methods to:
The identification of CRT responders, as defined by echocardiography, generally refers to a significant reduction of the LV End-Systolic Diameter (LVESD) and/or LVESV during Follow-Up (FUp).
Patients will be considered as responders to CRT if their LVESV decreased by > 15% after 6 months of CRT therapy as compared to baseline. The percentage of CRT responders will be compared between the two study arms.
SoC is defined as the standard CRT system programming/optimization method currently used by physicians in study centers and any method may be used in the study if considered as routine practice in the study center.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 348 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →MicroPort CRM is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CRT-D device with the SonR optimization algorithm programmed being 'on'.
Device: SonR CRT Optimization 'On'
CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).
Device: SonR CRT Optimization 'Off'
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).
CRT-responders rate increase based on LVESV decrease at M6 / baseline
For the purpose of this study, CRT-responders are defined as patients experiencing a decrease in LVESV of 15% or more at M6 Fup as most clinical trials used. The main objective of the SONR-ECHO trial is to show a minimum increase of CRT-responders rate of 15% (up to 72% or more) in the SonR study group as compared to SoC arm.
Time frame: 6 months
A-wave truncation assessment at M6
The Ritter's method attempts to optimize AV and VV timings in dual-chamber PM patients. According to this method, AV delay is optimal when LVFT is maximal and mitral valve closure only occurs after atrial systole (A-wave) is complete.
Time frame: 6 months
Report LV remodeling from LVEDV decrease at M6 / baseline
LVEDV is a standard marker of CRT effectiveness. Echocardiographic data collected at M6 FUp will document the evolution of LVEDV as compared to baseline in order to assess CRT effectiveness.
Time frame: 6 months
LVEF increase at M6
LVEF, as a surrogate of LVESV and LVEDV, is a standard marker of CRT effectiveness. Echocardiographic data collected at M6 FUp will document the evolution of LVEF as compared to baseline in order to assess CRT effectiveness.
Time frame: 6 months
AF analysis during FUp
Sorin commercialized CRT-D device offering both SonR optimization algorithm and atrio biventricular provides a performing Mode Switch (MS) function able to store and document sustained AF episodes during FUp. The MS data stored inSorin commercialized CRT-D device offering both SonR optimization algorithm and atrio biventricular memories will be collected at each FUp in order to report total AF burden, permanent AF and AF event free-rate in both arms up to M6 FUp.
Time frame: 6 months
AF-related events
Number of AF-events per patients, the event type, time to the first occurrence, the survival (event-free) curves will be reported per study group.
Time frame: 6 months
LA and RV functions
Echocardiographic data from each exam will be analyzed in order to report the evolution of the diastolic and systolic functions of the LA and of the RV per study group.
Time frame: 6 months
Adverse events
All AEs observed during FUp in all study patients will be classified by origin, symptoms, severity, treatment and outcome per study arm.
Time frame: 6 months
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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