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

NCT01869062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2019-03-22

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • François Philippon · Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-05-19
Completion
2016-05-19

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01869062 on ClinicalTrials.gov