NCT02250547

Optimization With SonR Method in the ClinicAl pRactice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 278 (estimated)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 delays in office, during follow-up visits, but also enable the automatic optimization that weekly optimize the AV and VV delays. For the reasons mentioned above, the sponsor expects that the SonR optimization method increases the number of patients optimized systematically at each follow-up The purpose of this study is to evaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in HF patients prevalently in sinus rhythm. The primary objective will be evaluated as the percentage of patients successfully optimized every month until M6. A patient is considered successfully optimized by the SonR during one month if at least one Atri-Ventricular (AV) or Ventricular-Ventricular (VV) optimization is completed by the SonR automatic optimization method during the month. Patients eligible for the analysis are those with SonR automatic optimization function enabled and at least 50% of the time in sinus rhythm

Conditions

• CRT Patients

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-01-01
• Completion: 2017-09-01
• First posted: 2014-09-26
• Last updated: 2017-11-14

Locations

21 sites across 6 countries: Austria, France, Germany, Italy, Portugal, Spain