NCT Number: NCT02250547
Optimization With SonR Method in the ClinicAl pRactice
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
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Allgemeines Krankenhaus Linz (AKH LINZ), Linz, Austria
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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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 outcomes
-
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
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Report system-related complications
Time frame: 6M
Report system-related complications
Sponsors and collaborators
Lead sponsor
LivaNova
Industry
Registry information
Acronym: OSCAR
Important dates
- Study start
- 2012
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Sep 26, 2014
- Registry last updated
- Nov 14, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.