Clinical Evaluation Of The PARADYM RF Device

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.

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.