Perioperative Management Evaluation in Patients With CIED

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKlinikum-Fuerth

About this trial

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 criteria

Qualifiers

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

Disqualifiers

no implanted CIED,

no data from any peri-interventional CIED interrogation available

Trial design

Treatments tested in this trial

  • surgery or catheter based cardiac procedure (catheter ablation)

Treatment groups

No treatment groups listed

Sponsors and collaborators

Klinikum-Fuerth

Lead sponsor

Klinikum Nürnberg

Collaborator