Clinical trial NCT02250547: Optimization With SonR Method in the ClinicAl pRactice
Official title: Optimization With SonR Method in the ClinicAl pRactice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CRT Patients
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac resyncronisation therapy - defibrillator (CRT-D) patients

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of patients with SonR automatic optimization function enabled at each follow-up
timeFrame: 6M
measure: Analyze the evolution of optimal AV and VV delays SonR optimized over time
timeFrame: 6M
measure: Report system-related complications
timeFrame: 6M
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz (AKH LINZ)
city: Corbeil Essonne
country: France
facility: CH Sud Francilien
city: Haguenau
country: France
facility: Centre Hospitalier de Haguenau
city: Jossigny
country: France
facility: CH de Marne la Vallée
city: Le Mans
country: France
facility: CMC du Mans - Pôle Santé Sud
city: Lille
country: France
facility: Polyclinique du Bois
city: Limoges
country: France
facility: Chu Dupuytren
city: Lomme
country: France
facility: CH St Philibert
city: Lyon
country: France
facility: CH St Joseph et St Luc
city: Marseille
country: France
facility: Polyclinique Beauregard
city: Montbéliard
country: France
facility: Centre hospitalier Belford Montbéliard
city: Poitiers
country: France
facility: CH Poitiers
city: Roubaix
country: France
facility: Hôpital Victor Provo
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus
city: Papenburg
country: Germany
facility: PAP2 - Kardiologische Praxis Papenburg
city: L'aquila
country: Italy
facility: Osp. S. Salvatore
city: Napoli
country: Italy
facility: S.Giovanni Bosco
city: Evora
country: Portugal
facility: Hospital Espírito Santo, E.P.E
city: Faro
country: Portugal
facility: Hospital Central Faro
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Evangelischen Krankenhaus Bielefeld - Germany
name: Carsten W Israel
role: PRINCIPAL_INVESTIGATOR
References: