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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SonR CRT Optimization 'On' | Other | CRT-D device with the SonR optimization algorithm programmed being 'on'. |
|
| SonR CRT Optimization 'Off' | Other | CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SonR CRT Optimization 'On' | Device | Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| LVEF increase at M6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Philippon | Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de Cardiologie et Pneumologie de Québec | Québec | G1V 4G5 | Canada |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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CRT-D device
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| SonR CRT Optimization 'Off' | Device | Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care). |
|
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. |
| 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. | 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. | 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. | 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. | 6 months |