Optimization With SonR Method in the ClinicAl pRactice

NCT ID: NCT02250547

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 278 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2017-09-30

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

Conditions

CRT Patients

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LivaNova

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carsten W Israel

Role: PRINCIPAL_INVESTIGATOR

Evangelischen Krankenhaus Bielefeld - Germany

Locations

Allgemeines Krankenhaus Linz (AKH LINZ)

Linz, , Austria

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, , France

Evangelisches Krankenhaus

Bielefeld, , Germany

PAP2 - Kardiologische Praxis Papenburg

Papenburg, , Germany

Osp. S. Salvatore

L’Aquila, , Italy

S.Giovanni Bosco

Napoli, , Italy

Hospital Espírito Santo, E.P.E

Evora, , Portugal

Hospital Central Faro

Faro, , Portugal

Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria

Lisbon, , Portugal

Hospital Universitario Virgen del Rocío

Seville, , Spain

Countries

Austria; France; Germany; Italy; Portugal; Spain

Other Identifiers

RCSY01 OSCAR

Identifier Type: -

Identifier Source: org_study_id