NCT01169272

Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device

Clinical Evaluation Of SonR Atrial Lead In Paradym RF Device SORIN GROUP'S New ICD Plateform

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sorin Group has developed a new atrial lead which is under evaluation during this study. The SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature; interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization. The new RV autothreshold algorithm has been implemented in the CRT-ICD and will help the physician in his diagnosis avoiding potential lost of capture. The ICD device has also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study. Finally, the study will report the electrical and handling performances of the new left ventricular lead.

Detailed description

In this study, the sponsor aims at: * Demonstrating the safety of the atrial SonR lead; * Demonstrating the performances of the right ventricular autothreshold algorithm ; * Reporting the adverse events documented in the study; * Reporting electrical performances of Sorin Group PARADYM ICD, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives; * Reporting the Sorin atrial SonR and Situs 2 MV left ventricular leads performances; * Reporting the SonR atrial lead mechanical handling. * Reporting all information from SonR sensor to validate the SonR data exploitation and the AVD/VVD optimization. * Reporting the Situs 2 MV LV lead mechanical handling. * Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data. Thus, this study intends to show that PARADYM RF ICD operate safely and appropriately in intended-use as part of an ICD system.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	CRT-SonR 9770	Active implantable defibrillator with capacity of cardiac resynchronization therapy

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-06-01
• Completion: 2012-06-01
• First posted: 2010-07-26
• Last updated: 2014-06-18

Locations

1 site across 1 country: France