RecruitingNCT04331249

Perioperative Management Evaluation in Patients With CIED

Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices


Sponsor

Klinikum-Fuerth

Enrollment

500 participants

Start Date

Nov 27, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • implanted CIED (e.g. pacemaker, ICD, CRT),
  • performed (non-CIED related) surgical or catheter-based procedure,
  • data from peri-procedural CIED interrogation available
  • age \>18 years

Exclusion Criteria2

  • no implanted CIED,
  • no data from any peri-interventional CIED interrogation available

Interventions

PROCEDUREsurgery or catheter based cardiac procedure (catheter ablation)

patients with implanted CIED (pacemaker, ICD or CRT) that undergo any surgery or any catheter based cardiac procedure (e.g. radiofrequency ablation)


Locations(2)

Klinikum Fuerth

Fürth, Bavaria, Germany

Klinikum Nuernberg

Nuremberg, Bavaria, Germany

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NCT04331249


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