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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

Study Description
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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

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 278 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Optimization With SonR Method in the ClinicAl pRactice
Actual Study Start Date : July 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : September 2017
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. 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

  3. Report system-related complications [ Time Frame: 6M ]
    Report system-related complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac resyncronisation therapy - defibrillator (CRT-D) patients
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250547


Locations
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Sponsors and Collaborators
LivaNova
Investigators
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Principal Investigator: Carsten W Israel Evangelischen Krankenhaus Bielefeld - Germany
More Information
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Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT02250547    
Other Study ID Numbers: RCSY01 OSCAR
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017