CRT Patients
Conditions
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 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
Interventions
None listed
Sponsors
LivaNova
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months | 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 AV or 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with SonR automatic optimization function enabled at each follow-up | 6M | The number of patients with automatic SonR optimization enabled over the total number of patients at: Implantation, Baseline, M6 |
| Analyze the evolution of optimal AV and VV delays SonR optimized over time | 6M | Compare the mean and the intra-patient AV and VV delays between consecutive follow-ups |
| Report system-related complications | 6M | Report system-related complications |
Countries
Austria, France, Germany, Italy, Portugal, Spain
Outcome results
None listed