Optimization With SonR Method in the ClinicAl pRactice

Completed

• Conditions: CRT Patients

• Registration Number: NCT02250547
• Lead Sponsor: LivaNova

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

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-26
• Primary Completion: 2017-01
• Study Completion: 2017-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (21)

Hospital Espírito Santo, E.P.E; 🇵🇹 Evora, Portugal

Chu Dupuytren; 🇫🇷 Limoges, France

CH St Joseph et St Luc; 🇫🇷 Lyon, France

CH Poitiers; 🇫🇷 Poitiers, France

Evangelisches Krankenhaus; 🇩🇪 Bielefeld, Germany

PAP2 - Kardiologische Praxis Papenburg; 🇩🇪 Papenburg, Germany

S.Giovanni Bosco; 🇮🇹 Napoli, Italy

CH Sud Francilien; 🇫🇷 Corbeil Essonne, France

Polyclinique Beauregard; 🇫🇷 Marseille, France

Allgemeines Krankenhaus Linz (AKH LINZ); 🇦🇹 Linz, Austria

Osp. S. Salvatore; 🇮🇹 L'aquila, Italy

Centre hospitalier Belford Montbéliard; 🇫🇷 Montbéliard, France

Hôpital Victor Provo; 🇫🇷 Roubaix, France

Centre Hospitalier de Haguenau; 🇫🇷 Haguenau, France

Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal

CMC du Mans - Pôle Santé Sud; 🇫🇷 Le Mans, France

Polyclinique du Bois; 🇫🇷 Lille, France

CH St Philibert; 🇫🇷 Lomme, France

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

CH de Marne la Vallée; 🇫🇷 Jossigny, France

Hospital Central Faro; 🇵🇹 Faro, Portugal