Clinical trial NCT01193634: Clinical Evaluation Of The PARADYM RF Device
Official title: Clinical Evaluation Of The PARADYM RF Device SORIN GROUP'S New IDC Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: ICD VR 9250, DR 9550 and CRT 9750 - PARADYM RF ICD
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

* In case of implantation of VR 9250: patient has been prescribed the implantation or replacement of a single-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of single-chamber ICD;
* In case of implantation of DR 9550: patient has been prescribed the implantation or replacement of a dual-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of dual-chamber ICD;
* In case of implantation of CRT 9750: patient has been prescribed the implantation or replacement of a triple-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC3 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of triple-chamber ICD;

Exclusion Criteria:

* 1 VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
* 2 VT/VF occurred during the acute phase of infarction (\< 3 weeks) or during an unstable ischemic phase;
* 3 VF was caused by electrocution;
* 4 Incessant VT/VF ;
* 5 Implanted pacemaker that is not going to be explanted or otherwise disabled;
* 6 Patient is unable to attend the scheduled follow-ups at the implanting centre;
* 7 Patient is already enrolled in another ongoing clinical study;
* 8 Patient is unable to understand the aim of the study and its procedure;
* 9 Patient refuses to cooperate;
* 10 Patient is unable or refuses to provide informed consent;
* 11 Patient is minor (less than 18-year old);
* 12 Patient is pregnant;
* 13 Patient has life expectancy of less than 1 year;
* 14 Patient is forfeiture of freedom or under guardianship.

Primary outcomes:
measure: Demonstration of the Right ventricular (RV) autothreshold algorithm performances
timeFrame: 1 month
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 12 months
measure: ICD electrical performances
timeFrame: 12 months
measure: Evaluation of the left ventricular lead performances
timeFrame: 12 months
measure: Evlauation of the Remote Monitoring Solution
timeFrame: 12 months
Other outcomes:
Locations:
city: München
country: Germany
facility: Sack
Study officials:
affiliation: Klinikum Schwabing München Germany
name: Sack SS Stefan, Pr
role: PRINCIPAL_INVESTIGATOR
References: