About this trial
Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest guidelines. However, compared to conventional device implantation, cardiac resynchronization, His bundle pacing and left bundle area pacing remain demanding procedures in the individual case. Goal of the single center observational "Pace conduct" study is to evaluate implantation success, safety and outcome of pacing methods that maintain physiologic ventricular activation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pacemaker or ICD Implantation aiming to avoid pacing induced ventricular dyssynchrony according to current guidelines
age >= 18 years
Disqualifiers
no informed consent for the procedure given
no follow-up data
Trial population
Patients undergoing Pacemaker or ICD Implantation according to current Guidelines with the aim to avoid pacing induced ventricular dyssynchrony. Subgroups according to type of device implanted, lead Position and programming.
Trial design
Cohort
Prospective
Treatments tested in this trial
cardiac implantable electronic device (CIED) implantation
DeviceCIED Implantation according to the Guidelines aiming to avoid pacing induced dyssynchrony
Treatment groups
Trial outcomes
Primary outcomes
CIED Implantation success
successful Pacemaker- or ICD implantation with effective pacing and acceptable pacing threshold in the targeted area
Secondary outcomes
pre-operative: Implantation related Patient characteristics
association with procedural and post-implant outcome
intra-procedural: implant success related with procedural characteristics
correlation of Implantation success with Patient characteristics and procedural technical Parameter, eg. use of an electroanatomic mapping system
peri-procedural: safety and radiation
Radiation exposure and number and type of all adverse Events and adverse device associated events
follow-up: device function
device parameter and programming during follow up
Sponsors and contacts
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Klinikum-Fuerth
Lead sponsor
University of Erlangen-Nürnberg
Collaborator
University of Trieste
Collaborator