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

Plain Language Summary

Simplified for easier understanding

This is an observational study looking at how patients with an implanted heart device — such as a pacemaker, defibrillator (ICD), or cardiac resynchronization device (CRT) — are managed when they need to undergo an unrelated surgery or heart procedure. Researchers want to understand current practices and outcomes around these situations. **You may be eligible if...** - You are 18 years or older - You have an implanted cardiac device (pacemaker, ICD, or CRT) - You have undergone a surgical or catheter-based procedure not related to your device - Data from device checks around the time of your procedure is available **You may NOT be eligible if...** - You do not have an implanted cardiac device - No device check data is available from around the time of your procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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