NCT01193634

Clinical Evaluation Of The PARADYM RF Device

Clinical Evaluation Of The PARADYM RF Device SORIN GROUP'S New IDC Platform

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features: The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding potential lost of capture. Then, the ICD devices have 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 the PARADYM RF clinical study, the sponsor aims at: * Demonstrating the performances of the right ventricular autothreshold algorithm ; * Reporting the adverse events documented in the study; * Reporting electrical performances of Sorin Group PARADYM ICDs, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives; * Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data. * Reporting the Situs 2 MV left ventricular lead performances; * Reporting the Situs 2 MV LV lead mechanical handling. Thus, this study intends to show that PARADYM RF ICDs operate safely and appropriately in intended-use as part of an ICD system.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	VR 9250 / DR 9550 / CRT 9750	Active implantable defibrillators range

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-09-02
• Last updated: 2014-06-18

Locations

1 site across 1 country: Germany