Condition: Cardiac Pacemaker Malfunction · ICD Malfunction · Cardiac Pacemaker Electrical Interference · Sponsor: Klinikum-Fuerth
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.
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
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| Klinikum Fuerth | Fürth, Bavaria, Germany | Recruiting |
| Klinikum Nuernberg | Nuremberg, Bavaria, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04331249