Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-28 @ 11:03 PM
Study NCT ID:
NCT01193634
Status:
COMPLETED
Last Update Posted:
2014-06-18
First Post:
2010-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation Of The PARADYM RF Device
Sponsor:
LivaNova
Organization:
Study Overview
Official Title:
Clinical Evaluation Of The PARADYM RF Device SORIN GROUP'S New IDC Platform
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: