CRT PatientsOSCARNCT02250547
Optimization With SonR Method in the ClinicAl pRactice
An observational study of CRT Patients, run by LivaNova at 21 sites in 6 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRT Patients
- How many people
- 278 participants
- Where
- 21 sitesin 6 countries
- Study dates
- Jul 2012to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac resyncronisation therapy - defibrillator (CRT-D) patients
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
France12 sites
CH Sud Francilien
Corbeil Essonne, 91100
Centre Hospitalier de Haguenau
Haguenau, 67500
CH de Marne la Vallée
Jossigny, 77600
CMC du Mans - Pôle Santé Sud
Le Mans, 72000
Polyclinique du Bois
Lille, 59003
Chu Dupuytren
Limoges, 87042
CH St Philibert
Lomme, 59462
CH St Joseph et St Luc
Lyon, 69365
Polyclinique Beauregard
Marseille, 13425
Centre hospitalier Belford Montbéliard
Montbéliard, 25209
CH Poitiers
Poitiers
Hôpital Victor Provo
Roubaix, 59056
Portugal3 sites
Hospital Espírito Santo, E.P.E
Evora, 7000-811
Hospital Central Faro
Faro, 8000-386
Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria
Lisbon, 1649
Germany2 sites
Evangelisches Krankenhaus
Bielefeld, 33617
PAP2 - Kardiologische Praxis Papenburg
Papenburg, 26871
About this study
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
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 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
Measured: 6M
Report system-related complications
Report system-related complications
Measured: 6M
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJul 2012
- Primary completionJan 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRT PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carsten W Israel, Principal investigator, Evangelischen Krankenhaus Bielefeld - Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250547
- Sponsor's protocol ID
- RCSY01 OSCAR
- Acronym
- OSCAR
- Status last verified
- Nov 2017
- First submitted
- 10 Jul 2013
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization With SonR Method in the ClinicAl pRactice
- ClinicalTrials.gov ID
- NCT02250547
- Acronym / sponsor ID
- OSCAR / RCSY01 OSCAR
- Conditions
- CRT Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac resyncronisation therapy - defibrillator (CRT-D) patients
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Percentage of patients with SonR automatic optimization function enabled at each follow-up
Time frame: 6M
Analyze the evolution of optimal AV and VV delays SonR optimized over time
Time frame: 6M
Report system-related complications
Time frame: 6M
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten W Israel principal investigator
Evangelischen Krankenhaus Bielefeld - Germany
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRT Patients, run by LivaNova at 21 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Portugal, Germany, Italy, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.