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Perioperative Management Evaluation in Patients With CIED

NCT04331249 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Cardiac Pacemaker Malfunction
  • ICD Malfunction
  • Cardiac Pacemaker Electrical Interference
  • Anesthesia Complication
  • Surgery--Complications

Interventions

PROCEDURE

surgery 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)

Sponsors & Collaborators

  • Klinikum Nürnberg

    collaborator OTHER

  • Klinikum-Fuerth

    lead OTHER

Principal Investigators

  • Dirk Bastian, MD · Klinikum Fuerth, European Society of Cardiology, European Heart Rhythm Society

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2025-12-31
Completion
2030-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331249 on ClinicalTrials.gov