Perioperative Management Evaluation in Patients With CIED
Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices
Klinikum-Fuerth
500 participants
Nov 27, 2018
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
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
patients with implanted CIED (pacemaker, ICD or CRT) that undergo any surgery or any catheter based cardiac procedure (e.g. radiofrequency ablation)
Locations(2)
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NCT04331249