NCT01869062

Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: MicroPort CRM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This study will evaluate the effectiveness of CRT-D SonR system as compared to SoC programming methods to: * Increase the rate of patients responding to CRT * Provide appropriate hemodynamic cardiac effect, as expected from the Ritter method. 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	SonR CRT Optimization 'On'	Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.
DEVICE	SonR CRT Optimization 'Off'	Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-05-19
• Completion: 2016-05-19
• First posted: 2013-06-05
• Last updated: 2019-03-22

Locations

1 site across 1 country: Canada