Actively Recruiting

Age: 18Years +
All Genders
NCT04331249

Perioperative Management Evaluation in Patients With CIED

Led by Klinikum-Fuerth · Updated on 2024-10-15

500

Participants Needed

2

Research Sites

631 weeks

Total Duration

On this page

Sponsors

K

Klinikum-Fuerth

Lead Sponsor

K

Klinikum Nürnberg

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Perioperative Management Evaluation in Patients With CIED

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Implanted cardiac electronic device (e.g., pacemaker, ICD, CRT)
  • Undergoing a non-CIED related surgical or catheter-based procedure
  • Data from peri-procedural CIED interrogation available
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • No implanted cardiac electronic device
  • No data from any peri-interventional CIED interrogation available

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Klinikum Fuerth

Fürth, Bavaria, Germany, 90766

Actively Recruiting

2

Klinikum Nuernberg

Nuremberg, Bavaria, Germany, 90471

Actively Recruiting

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Research Team

D

Dirk Bastian, MD

CONTACT

L

Laura Vitali-Serdoz, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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