Status:
COMPLETED
Clinical Evaluation Of The PARADYM RF Device
Lead Sponsor:
LivaNova
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 capt...
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; * Re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01193634
Start Date
October 1 2010
End Date
March 1 2012
Last Update
June 18 2014
Active Locations (1)
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1
Sack
München, Germany, 80804