Status:
COMPLETED
Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device
Lead Sponsor:
LivaNova
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 (V...
Detailed Description
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 eve...
Eligibility Criteria
Inclusion
- Patient eligible for implantation of a CRT 9770 device accordingly to the relevant currently-approved ACC/AHA/ESC guidelines or any relevant currently approved local guidelines for the implantation or replacement of triple-chamber ICD
- Implanted with atrial SonR lead
- Signed and dated informed consent
Exclusion
- VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
- VT/VF occurred during the acute phase of infarction (\< 3 weeks) or during an unstable ischemic phase;
- VF was caused by electrocution;
- Incessant VT/VF;
- Patient is unable to attend the scheduled follow-ups at the implanting centre;
- Patient is already enrolled in another ongoing clinical study;
- Patient is unable to understand the aim of the study and its procedure;
- Patient refuses to cooperate;
- Patient is unable or refuses to provide informed consent;
- Patient is minor (less than 18-year old);
- Patient is pregnant;
- Patient has life expectancy of less than 1 year;
- Patient is forfeiture of freedom or under guardianship.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01169272
Start Date
October 1 2010
End Date
June 1 2012
Last Update
June 18 2014
Active Locations (1)
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1
Leclercq
Rennes, France, 35033