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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
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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with SonR automatic optimization function enabled at each follow-up | The number of patients with automatic SonR optimization enabled over the total number of patients at: Implantation, Baseline, M6 | 6M |
| Analyze the evolution of optimal AV and VV delays SonR optimized over time |
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Inclusion Criteria:
Exclusion Criteria:
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Cardiac resyncronisation therapy - defibrillator (CRT-D) patients
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| Name | Affiliation | Role |
|---|---|---|
| Carsten W Israel | Evangelischen Krankenhaus Bielefeld - Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus Linz (AKH LINZ) | Linz | Austria | ||||
| CH Sud Francilien |
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Compare the mean and the intra-patient AV and VV delays between consecutive follow-ups |
| 6M |
| Report system-related complications | Report system-related complications | 6M |
| Corbeil Essonne |
| 91100 |
| France |
| Centre Hospitalier de Haguenau | Haguenau | 67500 | France |
| CH de Marne la Vallée | Jossigny | 77600 | France |
| CMC du Mans - Pôle Santé Sud | Le Mans | 72000 | France |
| Polyclinique du Bois | Lille | 59003 | France |
| Chu Dupuytren | Limoges | 87042 | France |
| CH St Philibert | Lomme | 59462 | France |
| CH St Joseph et St Luc | Lyon | 69365 | France |
| Polyclinique Beauregard | Marseille | 13425 | France |
| Centre hospitalier Belford Montbéliard | Montbéliard | 25209 | France |
| CH Poitiers | Poitiers | France |
| Hôpital Victor Provo | Roubaix | 59056 | France |
| Evangelisches Krankenhaus | Bielefeld | 33617 | Germany |
| PAP2 - Kardiologische Praxis Papenburg | Papenburg | 26871 | Germany |
| Osp. S. Salvatore | L’Aquila | 67100 | Italy |
| S.Giovanni Bosco | Naples | Italy |
| Hospital Espírito Santo, E.P.E | Evora | 7000-811 | Portugal |
| Hospital Central Faro | Faro | 8000-386 | Portugal |
| Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria | Lisbon | 1649 | Portugal |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |