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Optimization With SonR Method in the ClinicAl pRactice (OSCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02250547
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
LivaNova

Tracking Information
First Submitted Date July 10, 2013
First Posted Date September 26, 2014
Last Update Posted Date November 14, 2017
Actual Study Start Date July 2012
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2014)
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 [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 25, 2014)
  • Percentage of patients with SonR automatic optimization function enabled at each follow-up [ Time Frame: 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 [ Time Frame: 6M ]
    Compare the mean and the intra-patient AV and VV delays between consecutive follow-ups
  • Report system-related complications [ Time Frame: 6M ]
    Report system-related complications
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optimization With SonR Method in the ClinicAl pRactice
Official Title Optimization With SonR Method in the ClinicAl pRactice
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cardiac resyncronisation therapy - defibrillator (CRT-D) patients
Condition CRT Patients
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: September 25, 2014)
278
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   France,   Germany,   Italy,   Portugal,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02250547
Other Study ID Numbers RCSY01 OSCAR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party LivaNova
Study Sponsor LivaNova
Collaborators Not Provided
Investigators
Principal Investigator: Carsten W Israel Evangelischen Krankenhaus Bielefeld - Germany
PRS Account LivaNova
Verification Date November 2017