CRT Patients Clinical Trial
— OSCAROfficial title:
Optimization With SonR Method in the ClinicAl pRactice
| Verified date | November 2017 |
| Source | LivaNova |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 278 |
| Est. completion date | September 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Allgemeines Krankenhaus Linz (AKH LINZ) | Linz | |
| France | CH Sud Francilien | Corbeil Essonne | |
| France | Centre Hospitalier de Haguenau | Haguenau | |
| France | CH de Marne la Vallée | Jossigny | |
| France | CMC du Mans - Pôle Santé Sud | Le Mans | |
| France | Polyclinique du Bois | Lille | |
| France | Chu Dupuytren | Limoges | |
| France | CH St Philibert | Lomme | |
| France | CH St Joseph et St Luc | Lyon | |
| France | Polyclinique Beauregard | Marseille | |
| France | Centre hospitalier Belford Montbéliard | Montbéliard | |
| France | CH Poitiers | Poitiers | |
| France | Hôpital Victor Provo | Roubaix | |
| Germany | Evangelisches Krankenhaus | Bielefeld | |
| Germany | PAP2 - Kardiologische Praxis Papenburg | Papenburg | |
| Italy | Osp. S. Salvatore | L'aquila | |
| Italy | S.Giovanni Bosco | Napoli | |
| Portugal | Hospital Espírito Santo, E.P.E | Evora | |
| Portugal | Hospital Central Faro | Faro | |
| Portugal | Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria | Lisboa | |
| Spain | Hospital Universitario Virgen del Rocío | Sevilla |
| Lead Sponsor | Collaborator |
|---|---|
| LivaNova |
Austria, France, Germany, Italy, Portugal, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | Analyze the evolution of optimal AV and VV delays SonR optimized over time | Compare the mean and the intra-patient AV and VV delays between consecutive follow-ups | 6M | |
| Secondary | Report system-related complications | Report system-related complications | 6M |