Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Clinical Evaluation Of SonR Atrial Lead In Paradym RF Device SORIN GROUP'S New ICD Plateform|
- Evaluation of the SonR lead safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Complication free rate of the SonR lead superior to 90 %
- Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Any adverse will be documented thoughout the study and will be reported.
- ICD electrical performances [ Time Frame: 12 months ] [ Designated as safety issue: No ]Report all ICD electrical performances of the Paradym RF ICD
- Evaluation of the SonR atrial lead performance [ Time Frame: 3 months ] [ Designated as safety issue: No ]Report electrical performances and lead handling at implant
- Evaluation of the AV/VV delays optimization [ Time Frame: 3 months ] [ Designated as safety issue: No ]Describe the performances of the manual and automatic AV/VV optimization algorithms. An optional daily life test could be performed to evaluate the automatic optimization at exercise.
- Evaluation of the left ventricular lead performances [ Time Frame: 12 months ] [ Designated as safety issue: No ]Report the electrical performances and lead mechanical handling at implant.
- Evaluation of the Remote Monitoring Solution [ Time Frame: 12 months ] [ Designated as safety issue: No ]Ensure the Home Monitor setup procedure and daily life use are user friendly for the patient and the back office is convenient for the physician.
- Evaluation of the right ventricular autothreshold performances [ Time Frame: 1 month ] [ Designated as safety issue: No ]Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test with an authorized error of 0,25V.
|Study Start Date:||October 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: CRT-SonR 9770
Active implantable defibrillator with ability to cardiac resynchronization therapy
Device: CRT-SonR 9770
Active implantable defibrillator with capacity of cardiac resynchronization therapy
Other Name: 9770
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169272
|Rennes, France, 35033|
|Principal Investigator:||Christophe CL Leclercq, Ryhtmologist||CHU Rennes|