Pacing to Maintain Physiologic Ventricular Activation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKlinikum-Fuerth

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • cardiac implantable electronic device (CIED) implantation

    Device

    CIED Implantation according to the Guidelines aiming to avoid pacing induced dyssynchrony

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: CIED for cardiac resynchronisation1 intervention

Trial outcomes

Primary outcomes

1

CIED Implantation success

successful Pacemaker- or ICD implantation with effective pacing and acceptable pacing threshold in the targeted area

Time frame
peri-procedural

Secondary outcomes

1

pre-operative: Implantation related Patient characteristics

association with procedural and post-implant outcome

Time frame
1 month post implantation
2

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

Time frame
peri-procedural
3

peri-procedural: safety and radiation

Radiation exposure and number and type of all adverse Events and adverse device associated events

Time frame
peri-procedural
4

follow-up: device function

device parameter and programming during follow up

Time frame
one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Klinikum-Fuerth

Lead sponsor

University of Erlangen-Nürnberg

Collaborator

University of Trieste

Collaborator