Optimization With SonR Method in the ClinicAl pRactice (OSCAR)

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

Study Overview

• Status: Completed
• Conditions: CRT Patients

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 Type: Observational
• Enrollment (Anticipated): 278

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Allgemeines Krankenhaus Linz (AKH LINZ)
• France
  • Corbeil Essonne, France, 91100
    • CH SUd Francilien
  • Haguenau, France, 67500
    • Centre Hospitalier de Haguenau
  • Jossigny, France, 77600
    • CH de Marne la Vallée
  • Le Mans, France, 72000
    • CMC du Mans - Pôle Santé Sud
  • Lille, France, 59003
    • Polyclinique Du Bois
  • Limoges, France, 87042
    • Chu Dupuytren
  • Lomme, France, 59462
    • CH St Philibert
  • Lyon, France, 69365
    • CH St Joseph et St Luc
  • Marseille, France, 13425
    • Polyclinique Beauregard
  • Montbéliard, France, 25209
    • Centre hospitalier Belford Montbéliard
  • Poitiers, France
    • CH Poitiers
  • Roubaix, France, 59056
    • Hôpital Victor Provo
• Germany
  • Bielefeld, Germany, 33617
    • Evangelisches Krankenhaus
  • Papenburg, Germany, 26871
    • PAP2 - Kardiologische Praxis Papenburg
• Italy
  • L'aquila, Italy, 67100
    • Osp. S. Salvatore
  • Napoli, Italy
    • S.Giovanni Bosco
• Portugal
  • Evora, Portugal, 7000-811
    • Hospital Espírito Santo, E.P.E
  • Faro, Portugal, 8000-386
    • Hospital Central Faro
  • Lisboa, Portugal, 1649
    • Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria
• Spain
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cardiac resyncronisation therapy - defibrillator (CRT-D) patients

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Principal Investigator: Carsten W Israel, Evangelischen Krankenhaus Bielefeld - Germany

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: RCSY01 OSCAR