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Study identifier: NCT04331249 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Perioperative Management Evaluation in Patients With CIED

Condition: Cardiac Pacemaker Malfunction · ICD Malfunction · Cardiac Pacemaker Electrical Interference  ·  Sponsor: Klinikum-Fuerth

PhaseN/A
Planned participants500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives. Objective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine. Study design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics Primary endpoint: number and type of peri-operative adverse device related events (ADE) Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery/intervention, anesthesiology techniques, any AE), postinterventional data (data from post-interventional CIED interrogation, need for reprogramming / device revision). Inclusion criteria: implanted CIED, non-CIED related surgical or catheter-based intervention, peri-procedural CIED interrogation, age \>18 years Exclusion criteria: no implanted CIED, no data from any peri-procedural CIED interrogation available Patient enrollment: retrospectively beginning from 2008, further on-going prospective inclusion Sample size: For the observational study, there is no pre-specified sample size. Data from more than 500 patients undergoing \> 700 interventions are expected.

This description comes directly from the study's public registry record.

Talk to the study team

Dirk Bastian, MD  ·  +49 (0)911 7580 1101  ·  dirk.bastian@klinikum-fuerth.de

Laura Vitali-Serdoz, MD  ·  +49 (0)911 7580 1101  ·  laura.vitali-serdoz@klinikum-fuerth.de

Always discuss trial participation with your own doctor first.

Locations (2)

Klinikum FuerthFürth, Bavaria, GermanyRecruiting
Klinikum NuernbergNuremberg, Bavaria, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT04331249