Status:
COMPLETED
Optimization With SonR Method in the ClinicAl pRactice
Lead Sponsor:
LivaNova
Conditions:
CRT Patients
Eligibility:
All Genders
18+ years
Brief Summary
Evaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in Heart failure (HF) patients prevalently in sinus rhythm
Detailed Description
Thanks to the SonR technology it is possible to adjust the optimal VV and AV delays over time, in a fully automatic, time saving and operator independent way. It is possible to optimize the VV and AV ...
Eligibility Criteria
Inclusion
- Patient eligible for implantation or implanted for less than 6 weeks (primo-implant, replacement, upgrade) with a a Paradym RF SonR CRT-D and SonRtip Atrial Lead, according to current available guidelines (RF=radio frequency)
- Patient has signed and dated informed consent (according to the laws and regulations of the country in which the observation is performed)
Exclusion
- Persistent atrial arrhythmias
- Already included in another interventional clinical study
- Not available for routine follow-up visits
- Inability to understand the purpose of the study
- Under guardianship
- Under18 years old
- Drug addiction or abuse
- Pregnancy
Key Trial Info
Start Date :
July 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT02250547
Start Date
July 1 2012
End Date
September 1 2017
Last Update
November 14 2017
Active Locations (21)
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1
Allgemeines Krankenhaus Linz (AKH LINZ)
Linz, Austria
2
CH Sud Francilien
Corbeil Essonne, France, 91100
3
Centre Hospitalier de Haguenau
Haguenau, France, 67500
4
CH de Marne la Vallée
Jossigny, France, 77600